Label: I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4214-1, 62742-4214-2
- Packager: Allure Labs
- 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 April 18, 2022
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- 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
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OTHER SAFETY INFORMATION
Sun Protection Measures: Spending time in the sun increases your risk of 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.
Other information • Protect the product in this container from excessive heat and direct sun.
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INACTIVE INGREDIENT
Inactive Ingredients Water/Aqua/Eau, Coconut Alkanes, Cyclopentasiloxane, Squalane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, lsohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone Crosspolymer, Hydrogen Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Magnesium Sulfate, Mica, Polyhydroxystearic Acid, Phenoxyethanol, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ettylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perfluorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europaea (Olive) Leaf Extract, Artemisia Vulgads Extract, Hyaluronic Acid, Laminaria Digitata Extract, Phospholipids, lsomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl PaImitate, Ascorbyl Palmitate, Tocopheryl Acetate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Beta-Carotene, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Tocopherol, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothioneine, Iron Oxides (CI 77492), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 85 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) GLYCERIN (UNII: PDC6A3C0OX) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PERFLUNAFENE (UNII: 54A06VV62N) ZINC PIDOLATE (UNII: C32PQ86DH4) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) ERGOTHIONEINE (UNII: BDZ3DQM98W) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) COCONUT ALKANES (UNII: 1E5KJY107T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2) DIPROPYLENE GLYCOL (UNII: E107L85C40) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) SODIUM CITRATE (UNII: 1Q73Q2JULR) BETA CAROTENE (UNII: 01YAE03M7J) SALICYLIC ACID (UNII: O414PZ4LPZ) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SORBIC ACID (UNII: X045WJ989B) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) HEXYL LAURATE (UNII: 4CG9F9W01Q) ISOHEXADECANE (UNII: 918X1OUF1E) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) CYCLOMETHICONE 6 (UNII: XHK3U310BA) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) WATER (UNII: 059QF0KO0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) LAMINARIA DIGITATA (UNII: 15E7C67EE8) ISOMALT (UNII: S870P55O2W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MICA (UNII: V8A1AW0880) ASCORBYL PALMITATE (UNII: QN83US2B0N) SODIUM BENZOATE (UNII: OJ245FE5EU) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM OXIDE (UNII: LMI26O6933) SQUALANE (UNII: GW89575KF9) HYALURONIC ACID (UNII: S270N0TRQY) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4214-2 1 in 1 CARTON 04/18/2022 1 NDC:62742-4214-1 28 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 04/18/2022 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4214)