FLASH RADIANT PRIMER- titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate cream

Flash Radiant Primer by

Drug Labeling and Warnings

Flash Radiant Primer by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate 5.00%

Ethylhexyl Salicylate 3.00%

Titanium Dioxide 2.84%

PURPOSE

Sunscreen

Helps prevent sunburn

INSTRUCTIONS FOR USE

Apply liberally 15 minutes before sun exposure

Reapply at least every two hours

Use a water resistant sunscreen if swimming or sweating

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 of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor.

For external use only

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.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

DO NOT USE

Do not use on damaged or broken skin.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENT

WATER

CYCLOPENTASILOXANE

GLYCERIN

TALC

PEG-10 DIMETHICONE

DIPROPYLENE GLYCOL

HEXYL LAURATE

ISOEICOSANE

NIACINAMIDE

CYCLOMETHICONE

DISTEARDIMONIUM HECTORITE

IRON OXIDES(CI 77492)

MAGNESIUM SULFATE

DIMETHICONE

C12-14 PARETH-3

ACRYLATES/DIMETHICONE COPOLYMER

PHENOXYETHANOL

METHICONE

ALUMINUM HYDROXIDE

IRON OXIDES(CI 77491)

ALUMINUM STEARATE

DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER

PALMITIC ACID

FRAGRANCE

BETAINE

ETHYLHEXYLGLYCERIN

TOCOPHERYL ACETATE

IRON OXIDES(CI 77499)

TRIETHOXYCAPRYLYLSILANE

ADENOSINE

AMINOPROPYL DIMETHICONE

POLYMETHYLSILSESQUIOXANE

CERAMIDE 3

COLLAGEN

GOLD

BUTYLENE GLYCOL

ONSEN-SUI

PRUNUS SERRULATA FLOWER EXTRACT

RICE FERMENT FILTRATE (SAKE)

MENTHYL PCA

ETHYL MENTHANE CARBOXAMIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLASH RADIANT PRIMER 
titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.136 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.2 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
MICA (UNII: V8A1AW0880)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DOCOSANOL (UNII: 9G1OE216XY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
METHYL METHACRYLATE (UNII: 196OC77688)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PURSLANE (UNII: M6S840WXG5)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
XANTHAN GUM (UNII: TTV12P4NEE)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
LEMON (UNII: 24RS0A988O)
TANGERINE (UNII: KH3E3096OO)
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8)
VANILLA (UNII: Q74T35078H)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-119-02	1 in 1 CARTON	01/31/2018
1	NDC: 43526-119-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/31/2018

Labeler - Inel Cosmetics Co., Ltd (688038939)

Registrant - Inel Cosmetics Co., Ltd (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(43526-119)