NDC Code(s) : 59779-383-06, 59779-383-03
Packager : CVS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sun Broad Spectrum SPF 30 Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0% Octocrylene 10.0% LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59779-383
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) 		HOMOSALATE10 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE10 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 809Y72KV36)
BENZYL ALCOHOL(UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CHLORPHENESIN(UNII: I670DAL4SZ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE(UNII: 3V5U97P248)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
OLETH-3(UNII: BQZ26235UC)
NEOPENTYL GLYCOL(UNII: QI80HXD6S5)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
SORBITOL(UNII: 506T60A25R)
TOCOPHEROL(UNII: R0ZB2556P8)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59779-383-06227 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:59779-383-0388.7 mL in 1 POUCH 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 11/06/2014

PRINCIPAL DISPLAY PANEL

Broad Spectrum SPF 30

UVA/UVB protection

Sunscreen

Moisturizing formula

Hypoallergenic

Water resistant (80 minutes)

COMPARE TO COPPERTONE

        ULTRAGUARD LOTION

   8.0 FL OZ (237 mL)

label