NDC Code(s) : 51060-029-01, 51060-030-01, 51060-031-01, 51060-032-01, 51060-033-01, 51060-034-01, 51060-035-01, 51060-036-01, 51060-037-01, 51060-038-01
Packager : Tarte, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-029
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-029-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-030-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-031
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-031-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-032-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-033
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-033-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-034
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-034-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-035
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-035-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-036
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-036-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-037-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012
Maracuja Miracle Foundation 12-Hour Foundation Broad Spectrum SPF 15 Sunscreen Avobenzone, Octinoxate, Octisalate, and Oxybenzone LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51060-038
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
cyclomethicone 5(UNII: 0THT5PCI0R)
mica(UNII: V8A1AW0880)
butylene glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
silicon dioxide(UNII: ETJ7Z6XBU4)
alkyl (c12-15) benzoate(UNII: A9EJ3J61HQ)
disteardimonium hectorite(UNII: X687XDK09L)
phenoxyethanol(UNII: HIE492ZZ3T)
benzotriazolyl dodecyl p-cresol(UNII: 298PX4M11X)
magnesium sulfate(UNII: DE08037SAB)
caprylyl glycol(UNII: 00YIU5438U)
polyglyceryl-4 isostearate(UNII: 820DPX33S7)
hexyl laurate(UNII: 4CG9F9W01Q)
yellow wax(UNII: 2ZA36H0S2V)
potassium sorbate(UNII: 1VPU26JZZ4)
glycereth-18 ethylhexanoate(UNII: IWS58C6V2Y)
boron nitride(UNII: 2U4T60A6YD)
C18-C21 alkane(UNII: 33822S0M40)
diethylene glycol monoethyl ether(UNII: A1A1I8X02B)
xanthan gum(UNII: TTV12P4NEE)
barium sulfate(UNII: 25BB7EKE2E)
1,2-hexanediol(UNII: TR046Y3K1G)
glycerin(UNII: PDC6A3C0OX)
benzoic acid(UNII: 8SKN0B0MIM)
glycereth-18(UNII: SA5E43C17C)
isododecane(UNII: A8289P68Y2)
caprylhydroxamic acid(UNII: UPY805K99W)
aluminum dimyristate(UNII: J2KA067N9O)
triethoxycaprylylsilane(UNII: LDC331P08E)
propylene carbonate(UNII: 8D08K3S51E)
allantoin(UNII: 344S277G0Z)
disodium stearoyl glutamate(UNII: 45ASM2L11M)
aluminum oxide(UNII: LMI26O6933)
stearic acid(UNII: 4ELV7Z65AP)
trehalose(UNII: B8WCK70T7I)
gold(UNII: 79Y1949PYO)
hexylene glycol(UNII: KEH0A3F75J)
passiflora edulis seed oil(UNII: F3VOA31UHQ)
passiflora incarnata seed oil(UNII: S0SU5AC95J)
sodium benzoate(UNII: OJ245FE5EU)
hyaluronate sodium(UNII: YSE9PPT4TH)
titanium dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51060-038-011 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 07/01/2012

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Ivory

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Fair

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Beige

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Light

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Warm Beige

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Light-to-Medium

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Medium

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Medium-to-Tan

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Tan

PRINCIPAL DISPLAY PANEL

tarte
high-performance naturals™

Broad Spectrum
SPF 15 Sunscreen

maracuja miracle
foundation

12-hour foundation

Principal Display Panel - 30 mL Bottle Carton - Deep