Label: COVER RECOVER SPF 30 IVORY- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4117-1, 62742-4117-2
- 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
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions: Apply immediately after treatment procedures, to dry clean skin, as a acamouflage for minor skin trauma. Apply daily after your skincare regime with DPDermaceuticals, as a corrective sunscreen foundation.
Sun protection measures: For sunscreen use
Apply for liberally 15 minutes before sun exposure. Re-apply every 2 hours, or after swimming or drying off with a towel. Prolonged exposure to the sun should be avoided, especially from 10:00am - 2:00pm. Suitable clothing such as long-sleeved shirt, hats, and sunglasses should be worn at all times in the sun. Use on children under 6 months ask a doctor.
- WARNINGS
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Cyclopentasiloxane, Dimethicone, Water (Aqua), Polyglyceryl-3-Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Bismuth Oxychloride, Butylene Glycol, Hydroxypropylcocoate PE-8 Dimethicone, Polyglyceryl-2 Diisostearate, Hydrated Silica, Mica, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Jojoba Esters, Cyclohexasiloxane, Biosaccharide Gum-1, Isohexadecane, PEG/PPG-18/18 Dimethicone, Glycerin, Pyrus Malus (Apple) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Mentha Piperita (Peppermint) Extract, Menthyl PCA, Sodium Hyaluronate, Copper Lysinate/Rolinate, Allantoin, Beta-Carotene, Hydrolyzed Vegetable Protein, Tocopherol, Adenosine Triphosphate, Saccharomyces Lysate Extract, Acetyl Tyrosine, Methylglucoside Phosphate, Retinyl Palmitate, Ascorbyl palmitate, Phospholipids, Proline, Ethyl menthane carboxamide, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Fragrance (Parfum), Triethoxycaprylysilane, Limonene, Linalool, citral, May contain:(+/-) Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COVER RECOVER SPF 30 IVORY
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 85.0 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P) HYDRATED SILICA (UNII: Y6O7T4G8P9) MICA (UNII: V8A1AW0880) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) ISOHEXADECANE (UNII: 918X1OUF1E) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) GLYCERIN (UNII: PDC6A3C0OX) APPLE (UNII: B423VGH5S9) VITIS VINIFERA SEED (UNII: C34U15ICXA) MENTHA PIPERITA (UNII: 79M2M2UDA9) MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) .BETA.-CAROTENE (UNII: 01YAE03M7J) TOCOPHEROL (UNII: R0ZB2556P8) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) N-ACETYLTYROSINE (UNII: DA8G610ZO5) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBYL PALMITATE (UNII: QN83US2B0N) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) PROLINE (UNII: 9DLQ4CIU6V) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+)- (UNII: F4VNO44C09) CITRAL (UNII: T7EU0O9VPP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4117-2 1 in 1 CARTON 12/05/2017 1 NDC:62742-4117-1 20 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 12/05/2017 Labeler - Allure Labs, Inc (926831603) Registrant - Allure Labs, Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs, Inc 926831603 manufacture(62742-4117)