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

I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Toffee by

Drug Labeling and Warnings

I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Toffee by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide - 8.5 %

Titanium Dioxide - 8.6%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

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

WARNINGS AND PRECAUTIONS

Warning:

• For external use only.

DO NOT USE

Do not use:

• on damaged or broken skin.

WHEN USING

When using this products:

• Keep out of eyes. If contact occurs rinse with water to remove.

STOP USE

Stop use and ask a doctor

• if skin irritation develops. 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If swallowed, get medical help or contact a Poison Control Center right away.
  

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.

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

Manufactured for:

IMAGE Skincare, Lantana, FL 33462 USA

Manufactured in USA from globally

sourced ingredients and components

www.ImageSkincare.com

INGREDIENTS AND APPEARANCE

I CONCEAL FLAWLESS FOUNDATION BROAD SPECTRUM SPF 30 SUNSCREEN TOFFEE 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4176
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	86 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: 62742-4176-2	1 in 1 CARTON	10/04/2019
1	NDC: 62742-4176-1	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)