Label: HYDRATING SPF 30- avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-1124-03, 0363-1124-06, 0363-1124-07 - Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 30, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%.....................................................................Sunscreen
Homosalate 10%....................................................................Sunscreen
Octisalate 5%.........................................................................Sunscreen
Octocrylene 10%....................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Aloe Barbadensis Leaf Extract, Benzyl Alcohol,
Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl
Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate,
Fragrance, Glycerin, Oleth-3, Polyamide-8, Retinyl Palmitate, Sodium
Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water. - Questions? 1-800-925-4733
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING SPF 30
avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 10 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) Benzyl Alcohol (UNII: LKG8494WBH) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Chlorphenesin (UNII: I670DAL4SZ) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexyl Palmitate (UNII: 2865993309) Glycerin (UNII: PDC6A3C0OX) Oleth-3 (UNII: BQZ26235UC) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Sodium Ascorbyl Phosphate (UNII: 836SJG51DR) Sorbitol (UNII: 506T60A25R) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1124-06 236 mL in 1 TUBE; Type 0: Not a Combination Product 11/16/2016 2 NDC:0363-1124-03 89 mL in 1 TUBE; Type 0: Not a Combination Product 11/16/2016 3 NDC:0363-1124-07 296 mL in 1 TUBE; Type 0: Not a Combination Product 11/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/16/2016 Labeler - Walgreens (008965063) Registrant - Product Quiest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quiest Mfg 927768135 manufacture(0363-1124) , label(0363-1124)
