Label: BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
- NDC Code(s): 53208-800-01
- Packager: LG HOUSEHOLD & HEALTH CARE LTD
- 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 December 13, 2021
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Inactive ingredients
WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), FRAGRANCE
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INGREDIENTS AND APPEARANCE
BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-800 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.285 g in 50 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 1.75 g in 50 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.825 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 g in 50 mL Inactive Ingredients Ingredient Name Strength DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DIMETHICONE (UNII: 92RU3N3Y1O) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) ZINC STEARATE (UNII: H92E6QA4FV) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) DIPROPYLENE GLYCOL (UNII: E107L85C40) TROMETHAMINE (UNII: 023C2WHX2V) STEARIC ACID (UNII: 4ELV7Z65AP) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) EDETATE TRISODIUM (UNII: 420IP921MB) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-800-01 2 in 1 BOX 04/27/2020 1 50 mL in 1 TUBE; 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 04/27/2020 Labeler - LG HOUSEHOLD & HEALTH CARE LTD (688276187) Establishment Name Address ID/FEI Business Operations fmg Co.Ltd 690188305 manufacture(53208-800)