Label: I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN SUEDE- zinc oxide and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4175-1, 62742-4175-2 - Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
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 October 4, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS AND PRECAUTIONS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions for Sunscreen use:
- Apply generously 15 minutes before sun exposer.
- Children under 6 months of age: ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Sun protection measures.Spending time in the sun increase 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 protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long sleeve shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Inactive Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Coconut Alkanes, Squalne, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Isohexadecane, Polyglyceryl-4 Isostearate, Vinyl Dimethicone/Lauryl Dimethicone, Dimethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Alumina, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Tetradecane, Mica, Cyclohexasiloxane, Magnesium Sulfate, Polyhydroxystearic Acid, Triethoxysilyethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexylglycerin, Hexylene Glycol, Dipotassium Glycyrrhizate, Perflurorodecalin, Zinc PCA, Saccharomyces Lysate Extract, Centella Asiatica Extract, Leuconostoc/Radish Root Ferment Filtrate, Olea Europa (Olive) Leaf Extract, Algae Extract, Phospholipids, Artemisia Vulgaris Extract, Hyaluronic Acid, Isomalt, Cyperus Rotundus Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthium Sibiricum Fruit Extract, Dipropylene Glycol, Retinyl Palmitate, Tocopherol, Ascorbyl Palmitate, Opuntia Ficus-Indica Stem Extract, Sodium Citrate, Sodium Benzoate, Phenoxyethanol, Potassium Sorbate, Salicylic Acid, Acetyl Hexapeptide-8, Sorbic Acid, Lecithin, Vitis Vinifera (Grape) Fruit Cell Extract, Pantearythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Ergothionine, [+/-: Ci 77163, Ci 77492, Ci 77491, Ci 77499, Beta-carotene].
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN SUEDE
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4175 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 98 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) COCONUT ALKANES (UNII: 1E5KJY107T) SQUALANE (UNII: GW89575KF9) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) HEXYL LAURATE (UNII: 4CG9F9W01Q) ISOHEXADECANE (UNII: 918X1OUF1E) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM OXIDE (UNII: LMI26O6933) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) TETRADECANE (UNII: 03LY784Y58) MICA (UNII: V8A1AW0880) CYCLOMETHICONE 6 (UNII: XHK3U310BA) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PERFLUNAFENE (UNII: 54A06VV62N) ZINC PIDOLATE (UNII: C32PQ86DH4) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) CENTELLA ASIATICA (UNII: 7M867G6T1U) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) LAMINARIA DIGITATA (UNII: 15E7C67EE8) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) HYALURONIC ACID (UNII: S270N0TRQY) ISOMALT (UNII: S870P55O2W) CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2) DIPROPYLENE GLYCOL (UNII: E107L85C40) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SALICYLIC ACID (UNII: O414PZ4LPZ) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SORBIC ACID (UNII: X045WJ989B) WINE GRAPE (UNII: 3GOV20705G) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) ERGOTHIONEINE (UNII: BDZ3DQM98W) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) BETA CAROTENE (UNII: 01YAE03M7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4175-2 1 in 1 CARTON 10/04/2019 1 NDC:62742-4175-1 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 10/04/2019 Labeler - Allure Labs Inc (926831603)