CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING- avobenzone, octinoxate, octocrylene, and oxybenzone emulsion

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING 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
OXYBENZONE 1.0%	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 (AQUA/EAU) DIPROPYLENE GLYCOL SD ALCOHOL 40-B GLYCERIN HYDROGENATED POLYDECENE XYLITOL DIMETHICONE ISODODECANE PEG/PPG-14/7 DIMETHYL ETHER PEG-5 GLYCERYL STEARATE SILICA ISOSTEARIC ACID TREHALOSE DIPHENYLSILOXY PHENYL TRIMETHICONE XANTHAN GUM TOCOPHERYL ACETATE PEG/PPG-17/4 DIMETHYL ETHER PHYTOSTERYL MACADAMIATE POLYQUATERNIUM-51 SODIUM ACETYLATED HYALURONATE GINKGO BILOBA LEAF EXTRACT PAEONIA ALBIFLORA ROOT EXTRACT CRATAEGUS MONOGYNA FLOWER EXTRACT CAFFEINE SERINE HYDROLYZED SILK 2-O-ETHYL ASCORBIC ACID BUPLEURUM FALCATUM ROOT EXTRACT UNCARIA GAMBIR EXTRACT ROSA ROXBURGHII FRUIT EXTRACT HYDROLYZED CONCHIOLIN PROTEIN PPG-17 TRIETHANOLAMINE GLYCERYL STEARATE SE BEHENYL ALCOHOL BEHENIC ACID STEARIC ACID BATYL ALCOHOL PEG-30 SOY STEROL THEANINE BUTYLENE GLYCOL CARBOMER DISODIUM EDTA CELLULOSE GUM SODIUM METAPHOSPHATE BHT ALCOHOL TOCOPHEROL METHYLPARABEN ETHYLPARABEN PHENOXYETHANOL BENZOIC ACID FRAGRANCE (PARFUM) TITANIUM DIOXIDE MICA IRON OXIDES

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 - 125 mL Bottle Carton

clé de peau
BEAUTÉ

protective fortifying emulsion
BROAD SPECTRUM SPF 22
SUNSCREEN

DIN 02440814

125mL 4.2 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING 
avobenzone, octinoxate, octocrylene, and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3200 mg  in 125 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	9472 mg  in 125 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2560 mg  in 125 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1280 mg  in 125 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
XYLITOL (UNII: VCQ006KQ1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOSTEARIC ACID (UNII: X33R8U0062)
TREHALOSE (UNII: B8WCK70T7I)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GINKGO (UNII: 19FUJ2C58T)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
CAFFEINE (UNII: 3G6A5W338E)
SERINE (UNII: 452VLY9402)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
PPG-17 (UNII: OV0Q322E0U)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BATILOL (UNII: 39YR661C4U)
THEANINE (UNII: 8021PR16QO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-259-10	1 in 1 CARTON	02/01/2016
1		125 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	02/01/2016

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-259) , analysis(58411-259)