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

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION. 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 un 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 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 DIPHENYLSILOXY PHENYL TRIMETHICONE XANTHAN GUM TREHALOSE TOCOPHERYL ACETATE PEG/PPG-17/4 DIMETHYL ETHER PHYTOSTERYL MACADAMIATE GINKGO BILOBA LEAF EXTRACT ANGELICA ACUTILOBA ROOT EXTRACT PAEONIA ALBIFLORA ROOT EXTRACT CRATAEGUS MONOGYNA FLOWER EXTRACT PANAX GINSENG ROOT EXTRACT GLYCINE ONONIS SPINOSA ROOT EXTRACT HYDROLYZED SILK ROSA CANINA FRUIT EXTRACT ZANTHOXYLUM PIPERITUM PEEL EXTRACT HIBISCUS ESCULENTUS FRUIT EXTRACT FAGUS SYLVATICA BUD EXTRACT SODIUM ACETYLATED HYALURONATE PERILLA OCYMOIDES LEAF EXTRACT ROSA ROXBURGHII FRUIT EXTRACT HYDROLYZED CONCHIOLIN PROTEIN ISODONIS JAPONICUS LEAF/STALK EXTRACT BUPLEURUM FALCATUM ROOT EXTRACT PPG-17 TRIETHANOLAMINE GLYCERYL STEARATE SE BEHENYL ALCOHOL BEHENIC ACID STEARIC ACID BUTYLENE GLYCOL BATYL ALCOHOL THEANINE PEG-30 PHYTOSTEROL CARBOMER DISODIUM EDTA ALCOHOL CELLULOSE GUM SODIUM METAPHOSPHATE BHT TOCOPHEROL METHYLPARABEN ETHYLPARABEN PHENOXYETHANOL BENZOIC ACID FRAGRANCE 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 - 30 mL Bottle Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING
EMULSION n

BROAD SPECTRUM
SPF 22
SUNSCREEN

30 mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-561
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.93 g  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.7528 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.744 g  in 30 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.372 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED POLYDECENE TYPE I (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)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
GINKGO (UNII: 19FUJ2C58T)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GLYCINE (UNII: TE7660XO1C)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BATILOL (UNII: 39YR661C4U)
THEANINE (UNII: 8021PR16QO)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-561-10	1 in 1 CARTON	03/01/2020
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 FINAL	part352	03/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)