NDC Code(s) : 59779-278-06, 59779-278-03
Packager : CVS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Broad Spectrum SPF 50 Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 7% Oxybenzone 4% LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59779-278
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE13 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE7 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYGLYCERYL-3 DISTEARATE(UNII: ZI1LK470XV)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
SORBITOL(UNII: 506T60A25R)
STEARIC ACID(UNII: 4ELV7Z65AP)
TOCOPHEROL(UNII: R0ZB2556P8)
TROLAMINE(UNII: 9O3K93S3TK)
EICOSYL POVIDONE(UNII: XQQ9MKE2BJ)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59779-278-06237 mL in 1 BOTTLE
2NDC:59779-278-0388.7 mL in 1 PATCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/06/2014

PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 50

UVA/UVB protection

Sunscreen

Moisturizing formula

Hypoallergenic

Water resistant (80 minutes)

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