I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY- zinc oxide and titanium dioxide cream 
Allure Labs

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.

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Drug Facts

Active Ingredients

Titanium Dioxide 6.5%

Zinc Oxide 8.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

On damaged or broken skin.

When using this product

Keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if • Rash occurs.

Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use • Apply generously 15 minutes before sun exposure. • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating: • immediately after towel drying. • at least every 2 hours.

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.

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)

I Conceal Mahogany

I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN MAHOGANY 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4214
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE85 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4214-21 in 1 CARTON04/18/2022
1NDC:62742-4214-128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/18/2022
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4214)

Revised: 4/2022
Document Id: dcba05ff-7a69-c5c0-e053-2a95a90a6129
Set id: dcba05ff-7a68-c5c0-e053-2a95a90a6129
Version: 1
Effective Time: 20220418
 
Allure Labs