Label: MINERAL FOUNDATION SPF 30-3W- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4097-1, 62742-4097-2 - 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 5, 2017
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
MINERAL FOUNDATION SPF 30-3W
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4097 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 55 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 44 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE (UNII: NMQ347994Z) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) PERFLUNAFENE (UNII: 54A06VV62N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) MAGNESIUM SILICATE (UNII: 9B9691B2N9) NYLON-12 (UNII: 446U8J075B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SANDALWOOD (UNII: 3641YW25N2) PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G) BARLEY (UNII: 5PWM7YLI7R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) CENTELLA ASIATICA (UNII: 7M867G6T1U) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4097-2 1 in 1 CARTON 12/05/2017 1 NDC:62742-4097-1 29.6 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 final part352 11/29/2017 Labeler - Allure Labs Inc. (926831603)
