Label: PETER ISLAND KIDS SUNSCREEN SPF 65- homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 50390-703-56 - Packager: AMWAY CORP.
- 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 November 26, 2012
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Inactive Ingredients
Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.
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INGREDIENTS AND APPEARANCE
PETER ISLAND KIDS SUNSCREEN SPF 65
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50390-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) DOCOSANOL (UNII: 9G1OE216XY) PALMITIC ACID (UNII: 2V16EO95H1) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) MYRISTYL ALCOHOL (UNII: V42034O9PU) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) CETYL ALCOHOL (UNII: 936JST6JCN) LAURYL ALCOHOL (UNII: 178A96NLP2) CHLORPHENESIN (UNII: I670DAL4SZ) PEG-100 STEARATE (UNII: YD01N1999R) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TRICAPRIN (UNII: O1PB8EU98M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50390-703-56 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/26/2012 Labeler - AMWAY CORP. (083416854)