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

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, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.0%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
OXYBENZONE 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 CYCLOPENTASILOXANE GLYCERIN DIISOPROPYL SEBACATE BUTYLENE GLYCOL DIETHYLHEXYL SUCCINATE SD ALCOHOL 40-B TREHALOSE PEG/PPG-14/7 DIMETHYL ETHER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER TOCOPHERYL ACETATE PEG/PPG-17/4 DIMETHYL ETHER PHYTOSTERYL MACADAMIATE POLYQUATERNIUM-51 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 BEHENETH-20 PPG-17 BEHENYL ALCOHOL CARBOMER POLYSORBATE 20 TRIETHANOLAMINE DISODIUM EDTA STEARYL ALCOHOL HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER THEANINE SODIUM CITRATE ALCOHOL SODIUM METAPHOSPHATE CITRIC ACID BHT TOCOPHEROL PHENOXYETHANOL METHYLPARABEN BENZOIC ACID FRAGRANCE MICA TITANIUM DIOXIDE 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 - 50 mL Container Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING CREAM n
BROAD SPECTRUM
SPF 22
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1030 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2524 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2575 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1030 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
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)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
BEHENETH-20 (UNII: BJ4GP2IFLN)
PPG-17 (UNII: OV0Q322E0U)
DOCOSANOL (UNII: 9G1OE216XY)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
THEANINE (UNII: 8021PR16QO)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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: 58411-455-50	1 in 1 CARTON	02/01/2019
1		50 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 final	part352	02/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-455) , ANALYSIS(58411-455)