Label: MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4154-1, 62742-4154-2
- 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
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
apply liberally 20 minutes before sun exposure.
use a water resistant sunscreen if swimming or sweating.
reapply:
immidiately aftr swimming, sweating or towel drying.
at least every 2 hours.
children under 6months: ask doctor
Sun protection measures:
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:
limit time in the sun, especially from 10:00 am to 2:00 pm.
wear long sleaved shirts, pants, hats and sun glasses.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Ascorbic Acid, Ascorbyl Palmitate, Acrylates/C10-3- Alkyl Acrylate Crosspolymer, Algae Extract, Artemesia Vulgaris Extract, Bisabolol, Butylene Glycol, C13-14 Isoparaffin, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citral, Citric Acid, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Fragrance*, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Imperata Cylindrica Root Extract, Laureth-7, Lecithin, Limonene, PEG-100 Stearate, PEG-8, Phenoxyethanol, Polyacrylamide Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Linoleate/Oleate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Obiquinone, Water (Aqua), Xanthan Gum. 100% Natural
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4154 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 50.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) .BETA.-BISABOLOL (UNII: LP618AV2EA) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER 934 (UNII: Z135WT9208) CETYL ALCOHOL (UNII: 936JST6JCN) CITRAL (UNII: T7EU0O9VPP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) SUNFLOWER OIL (UNII: 3W1JG795YI) HEXYLENE GLYCOL (UNII: KEH0A3F75J) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) LAURETH-7 (UNII: Z95S6G8201) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LIMONENE, (+)- (UNII: GFD7C86Q1W) PEG-100 STEARATE (UNII: YD01N1999R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) UBIQUINONE Q2 (UNII: I7T5V2W47R) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4154-2 1 in 1 CARTON 12/12/2017 1 NDC:62742-4154-1 94.5 mL in 1 BOTTLE; 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) Registrant - Allure Labs, Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs, Inc 926831603 manufacture(62742-4154)
