Label: SHEER ZINC SPF 30- zinc oxide cream
- NDC Code(s): 62742-4199-1, 62742-4199-2
- 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 17, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
-
INACTIVE INGREDIENT
Inactive Ingredients: Water (Aqua), Cyclopentasiloxane , Butylene Glycol, Glycerin , Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone , Cyclohexasiloxane , Dimethicone , Sorbitan Stearate , Caprylic/Capric Triglyceride, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl Glycol , Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol , Lecithin , Tocopherol , Ascorbyl Palmitate, Ascorbic Acid, Citric Acid , Xanthan Gum, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract , Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract , Micrococcus Lysate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer , Tetrahexyldecyl Ascorbate , Bis(Cyano Butylacetate) Anthracenediylidene, Propylene Glycol , Caesalpinia spinosa Fruit Pod Extract , Helianthus Annuus(Sunflower) Sprout Extract, Sodium Benzoate , Potassium Sorbate, Rosa Damascena Flower Extract , 1,2-Hexanediol
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SHEER ZINC SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4199 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 186 mg in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) BUTYL CYANOACETATE (UNII: F9H6L20VOH) HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBIC ACID (UNII: PQ6CK8PD0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) PEG-100 STEARATE (UNII: YD01N1999R) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) LAURETH-7 (UNII: Z95S6G8201) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DIMETHICONE (UNII: 92RU3N3Y1O) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETYL ALCOHOL (UNII: 936JST6JCN) TOCOPHEROL (UNII: R0ZB2556P8) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SODIUM LACTATE (UNII: TU7HW0W0QT) DATE (UNII: H3O7QI5HY7) ASCORBYL PALMITATE (UNII: QN83US2B0N) TEPRENONE (UNII: S8S8451A4O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ROSA DAMASCENA FLOWER (UNII: JWB78P295A) CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4199-2 1 in 1 CARTON 12/17/2020 1 NDC:62742-4199-1 56.7 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 12/17/2020 Labeler - Allure Labs Inc. (926831603) Registrant - Allure Labs Inc. (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4199)
