I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN DEEP HONEY- 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 Ingredient

Titanium Dioxide 5.8 %

Zinc Oxide 8.5 %

Purpose

Sunscreen

Uses

Help prevent sunburn

If used as dircted 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 aske 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 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 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.

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)].

I Conceal Deep honey

I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN DEEP HONEY 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4213
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 DIOXIDE58 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4213-21 in 1 CARTON04/12/2022
1NDC:62742-4213-128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/12/2022
Labeler - Allure Labs (926831603)
Registrant - Allure Labs (926831603)
Establishment
NameAddressID/FEIBusiness Operations
Allure Labs926831603manufacture(62742-4213)

Revised: 4/2022
Document Id: dc792777-d8b7-3ebc-e053-2a95a90abc3f
Set id: dc792777-d8b6-3ebc-e053-2a95a90abc3f
Version: 1
Effective Time: 20220412
 
Allure Labs