NDC Code(s) : 50184-1053-1, 50184-1054-1, 50184-1055-1, 50184-1056-1, 50184-1057-1, 50184-1058-1, 50184-1059-1, 50184-1050-1
Packager : Philosophy, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1053
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1053-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1054
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1054-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1055
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1055-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1056
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1056-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1057
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1057-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1058
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1058-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1059
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1059-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016
Take A Deep Breath Cushion Foundation SPF 20 Shade xxTitanium Dioxide and Octinoxate LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50184-1050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.253 g in 13 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.525 g in 13 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (50 CST)(UNII: YP714N2H05)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED(UNII: 2PDG9JR76G)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
METHICONE (20 CST)(UNII: 6777U11MKT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)
CAFFEINE(UNII: 3G6A5W338E)
TROPOLONE(UNII: 7L6DL16P1T)
YEAST, UNSPECIFIED(UNII: 3NY3SM6B8U)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
HORDEUM VULGARE TOP(UNII: 86507VZR9K)
MILLETTIA PINNATA SEED(UNII: C2BRV53B1V)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ARABICA COFFEE BEAN(UNII: 3SW678MX72)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
ROSEMARY(UNII: IJ67X351P9)
CITRUS AURANTIUM FRUIT RIND(UNII: 055456JHI7)
ANGELICA ARCHANGELICA ROOT(UNII: DTN01M69SN)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
SORBIC ACID(UNII: X045WJ989B)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50184-1050-11 in 1 CARTON
113 mL in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2016

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 3 Carton LabelPrincipal Display Panel - Shade 3 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 4 Carton LabelPrincipal Display Panel - Shade 4 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 5 Carton LabelPrincipal Display Panel - Shade 5 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 6 Carton LabelPrincipal Display Panel - Shade 6 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 7 Carton LabelPrincipal Display Panel - Shade 7 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 8 Carton LabelPrincipal Display Panel - Shade 8 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 9 Carton LabelPrincipal Display Panel - Shade 9 Carton Label

PRINCIPAL DISPLAY PANEL

take a deep
breath

cushion foundation
with clean-air technology™

broad spectrum spf 20 sunscreen

philosophy: you see life more clearly
when you take a moment to breathe.

skin. color.

13 ml/0.44 fl. oz.

Principal Display Panel - Shade 10 Carton LabelPrincipal Display Panel - Shade 10 Carton Label