Label: QUENCH AND PROTECT HYDRATING SPF 30- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4158-1, 62742-4158-2 - Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 12, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract, Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl, Polydimethylsiloxyethyl HexylDimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, , Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUENCH AND PROTECT HYDRATING SPF 30
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4158 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 47 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83) DIMETHICONE (UNII: 92RU3N3Y1O) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCERIN (UNII: PDC6A3C0OX) CETEARYL OLIVATE (UNII: 58B69Q84JO) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) HEXYL LAURATE (UNII: 4CG9F9W01Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) PICHIA JADINII (UNII: 8JRL032K80) SORBITAN OLIVATE (UNII: MDL271E3GR) PANTHENOL (UNII: WV9CM0O67Z) PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4158-2 1 in 1 CARTON 12/12/2017 1 NDC:62742-4158-1 57 g 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 final part352 12/12/2017 Labeler - Allure Labs Inc (926831603)
