CLAMUE HEALTHY FRESH BB CREAM MEDIUM- titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate, zinc oxide cream
Inel Cosmetics Co., Ltd

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

Titanium Dioxide 10.05%

Ethylhexyl Methoxycinnamate 7.0%

Ethylhexyl Salicylate 5.0%

Zinc Oxide 3.48%

Sunscreen

Helps prevent sunburn

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

Stop use and ask a doctor if rash occurs.

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

Do not use on damaged or broken skin.

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

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

BB medium

CLAMUE HEALTHY FRESH BB CREAM MEDIUM
titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43526-117
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.02 mg in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 mg in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mg in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.392 mg in 40 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOEICOSANE (UNII: AR294KAG3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE (UNII: NMQ347994Z)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITIC ACID (UNII: 2V16EO95H1)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ADENOSINE (UNII: K72T3FS567)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CERAMIDE 3 (UNII: 4370DF050B)
PORK COLLAGEN (UNII: I8442U2G7J)
GOLD (UNII: 79Y1949PYO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43526-117-02	1 in 1 CARTON	07/29/2014	02/01/2018
1	NDC:43526-117-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/29/2014	02/01/2018

Labeler - Inel Cosmetics Co., Ltd (688038939)

Registrant - Inel Cosmetics Co., Ltd (688038939)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co., Ltd.		689512611	manufacture(43526-117)

Revised: 2/2018

Document Id: bd5db9d7-b52e-475b-8161-86447f7fecb6

Set id: 68708418-e8f6-46f9-8b91-247372d86411

Version: 4

Effective Time: 20180201

Inel Cosmetics Co., Ltd