Label: I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN DEEP HONEY- zinc oxide and titanium dioxide cream
- NDC Code(s): 62742-4213-1, 62742-4213-2
- 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 12, 2022
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
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 suncreen with a broad spectrum SPF valu of 15 or higer and other sun protection
measures including
limit time in the sun,especially from 10 am -2 pm
wear long sleeved shirts, pants,hats and sunglassess
Other information
Protect the product in this container from excessive heat and direct sun.
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INACTIVE INGREDIENT
AQUA/WATER/EAU,COCONUT ALKANES,
CYCLOPENTASILOXANE,SQUALANE,POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE
GLYCERIN,SILICA,CETYL PEG/PPG-10/1 DIMETHICONE,
HEXYL LAURATE,ISOHEXADECANE,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,
TRIETHOXYSIMETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE,
CAPRYLYL GLYCOL,DIMETHICONE/PEG-10/15 CROSSPOLYMER,
ETHYLHEXYLGLYCERIN,HEXYLENE GLYCOL,DIPOTASSIUM GLYCYRRHIZATE,
PERFLUORODECALIN,ZINC PCA,SACCHAROMYCES LYSATE EXTRACT,
CENTELLA ASIATICA EXTRACT,LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE,
OLEA EUROPAEA (OLIVE) LEAF EXTRACT,ARTEMISIA VULGARIS EXTRACT,
HYALURONIC ACID,LAMINARIA DIGITATA EXTRACT,PHOSPHOLIPIDS,ISOMALT,
CYPERUS ROTUNDUS ROOT EXTRACT,LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT,
XANTHIUM SIBIRICUM FRUIT EXTRACT,DIPROPYLENE GLYCOL,RETINYL PALMITATE,
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 DEEP HONEY
zinc oxide and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4213 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 58 mg in 1 g Inactive Ingredients Ingredient Name Strength SQUALANE (UNII: GW89575KF9) ISOHEXADECANE (UNII: 918X1OUF1E) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) SODIUM CITRATE (UNII: 1Q73Q2JULR) HEXYL LAURATE (UNII: 4CG9F9W01Q) BETA CAROTENE (UNII: 01YAE03M7J) SALICYLIC ACID (UNII: O414PZ4LPZ) ERGOTHIONEINE (UNII: BDZ3DQM98W) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959) XANTHIUM SIBIRICUM FRUIT (UNII: 3H333L84C2) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR) DIMETHICONE (UNII: 92RU3N3Y1O) LAMINARIA DIGITATA (UNII: 15E7C67EE8) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PERFLUNAFENE (UNII: 54A06VV62N) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) WINE GRAPE (UNII: 3GOV20705G) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) ALUMINUM OXIDE (UNII: LMI26O6933) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIPROPYLENE GLYCOL (UNII: E107L85C40) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) SORBIC ACID (UNII: X045WJ989B) TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ZINC PIDOLATE (UNII: C32PQ86DH4) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) HYALURONIC ACID (UNII: S270N0TRQY) ISOMALT (UNII: S870P55O2W) ASCORBYL PALMITATE (UNII: QN83US2B0N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FERROSOFERRIC OXIDE (UNII: XM0M87F357) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) MICA (UNII: V8A1AW0880) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) COCONUT ALKANES (UNII: 1E5KJY107T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4213-2 1 in 1 CARTON 04/12/2022 1 NDC:62742-4213-1 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 04/12/2022 Labeler - Allure Labs (926831603) Registrant - Allure Labs (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs 926831603 manufacture(62742-4213)
