Label: NO MAKEUP FOUNDATION FAIR BROAD SPECTRUM SPF 30- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4100-1, 62742-4100-2 - 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 November 30, 2017
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
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DirectionsApply evenly with your fingertips and blending product in circular motions. Can be re-applied as necessary to build desired coverage.
For sunscreen use:apply liberally 15 minutes before sun exposure.use water resistant sunscreen if swimming or sweating.reapply at least every 2 hours.not for use on children.Sun Protection Measures. Spending time in the sun increase your risk to skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasses.
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INACTIVE INGREDIENT
Inactive Ingredients:
Water/Aqua/Eau, cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, caprylic/Capric Triglyceride, Dimethicone, Sorbitan Stearate, Ethylhexyl palmitate, Cyclohexasiloxane, Aluminum Hydroxide, Stearic Acid, C12-15 Alkyl Benzoate, Triethoxysilylethyl Polydimethyliloxyethyl Hexyl Dimethicone, Tetrhexyldecyl Ascorbate, Dimethyl MEA, Mica, Phenoxyethanol, Glycolic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499), Lecithin, Tocopheryl Linoleate/Oleate, Cetyl Alcohol, Caprylyl Glycol, Tribeheniin, citric Acid, Xanthan Gum, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Fragrance/Parfum, Polyacrylamide, Sodium Lactate, C13-14 Isoparaffin, Dipotassium Glycyrrhizate, Disodium ESTA, Tocopherol, Ceramide NG, Phoenix Dactylifera (Date) Fruit Extract, Silica Dimethyl Silylate, PEG-10 Rapeseed Sterol, Thioctic acid, Silica, Sodiu Hylarunate, Palmitoyl Hexapeptide-12, Limonene, Linalool
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NO MAKEUP FOUNDATION FAIR BROAD SPECTRUM SPF 30
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4100 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 128.8 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 33.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ETHYLHEXYL PALMITATE (UNII: 2865993309) CYCLOMETHICONE 6 (UNII: XHK3U310BA) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) DEANOL (UNII: 2N6K9DRA24) MICA (UNII: V8A1AW0880) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCOLIC ACID (UNII: 0WT12SX38S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED) CETYL ALCOHOL (UNII: 936JST6JCN) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIBEHENIN (UNII: 8OC9U7TQZ0) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) SODIUM LACTATE (UNII: TU7HW0W0QT) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE NG (UNII: C04977SRJ5) DATE (UNII: H3O7QI5HY7) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) THIOCTIC ACID (UNII: 73Y7P0K73Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4100-2 1 in 1 CARTON 11/30/2017 1 NDC:62742-4100-1 30 mL in 1 BOTTLE, DROPPER; 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 11/30/2017 Labeler - Allure Labs, Inc (926831603)
