CLE DE PEAU BEAUTE SHEER FLUID VEIL- avobenzone, octinoxate, and octocrylene cream

CLE DE PEAU BEAUTE SHEER FLUID VEIL by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE SHEER FLUID VEIL by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply 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 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
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER∙SD ALCOHOL 40-B∙BUTYLENE GLYCOL∙XYLITOL∙DIMETHICONE∙TALC∙GLYCERIN∙POLYMETHYL METHACRYLATE∙PEG/PPG-19/19 DIMETHICONE∙HYDROGENATED POLYISOBUTENE∙XANTHAN GUM∙ERYTHRITOL∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙PPG-17∙DISODIUM EDTA∙PEG-60 GLYCERYL ISOSTEARATE∙TRIETHANOLAMINE∙CARBOMER∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙SODIUM METAPHOSPHATE∙BHT∙TOCOPHEROL∙SODIUM METABISULFITE∙POLYMETHYLSILSESQUIOXANE∙ALCOHOL∙FRAGRANCE∙IRON OXIDES∙MICA∙TITANIUM DIOXIDE∙

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

clé de peau
BEAUTÉ

sheer fluid veil

BROAD SPECTRUM
SPF 21
SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SHEER FLUID VEIL 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	771 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2282 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	617 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XYLITOL (UNII: VCQ006KQ1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
XANTHAN GUM (UNII: TTV12P4NEE)
ERYTHRITOL (UNII: RA96B954X6)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
PPG-17 (UNII: OV0Q322E0U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALCOHOL (UNII: 3K9958V90M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-206-10	1 in 1 CARTON	09/01/2014
1		30 mL in 1 BOTTLE; 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	09/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-206) , analysis(58411-206)