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 2.0%	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 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

WATERCYCLOPENTASILOXANEGLYCERINDIISOPROPYL SEBACATEBUTYLENE GLYCOLDIETHYLHEXYL SUCCINATESD ALCOHOL 40-BTREHALOSEPEG/PPG-14/7 DIMETHYL ETHERDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERTOCOPHERYL ACETATEPEG/PPG-17/4 DIMETHYL ETHERPHYTOSTERYL MACADAMIATEPOLYQUATERNIUM-51GINKGO BILOBA LEAF EXTRACTANGELICA ACUTILOBA ROOT EXTRACTPAEONIA ALBIFLORA ROOT EXTRACTCRATAEGUS MONOGYNA FLOWER EXTRACTPANAX GINSENG ROOT EXTRACTGLYCINEONONIS SPINOSA ROOT EXTRACTHYDROLYZED SILKROSA CANINA FRUIT EXTRACTZANTHOXYLUM PIPERITUM PEEL EXTRACTHIBISCUS ESCULENTUS FRUIT EXTRACTFAGUS SYLVATICA BUD EXTRACTSODIUM ACETYLATED HYALURONATEPERILLA OCYMOIDES LEAF EXTRACTROSA ROXBURGHII FRUIT EXTRACTHYDROLYZED CONCHIOLIN PROTEINISODONIS JAPONICUS LEAF/STALK EXTRACTBUPLEURUM FALCATUM ROOT EXTRACTBEHENETH-20PPG-17BEHENYL ALCOHOLCARBOMERPOLYSORBATE 20TRIETHANOLAMINEDISODIUM EDTASTEARYL ALCOHOLHYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHERTHEANINESODIUM CITRATEALCOHOLSODIUM METAPHOSPHATECITRIC ACIDBHTTOCOPHEROLPHENOXYETHANOLMETHYLPARABENBENZOIC ACIDFRAGRANCEMICATITANIUM DIOXIDEIRON 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 - 12 mL Bottle Carton

clé de peau
BEAUTÉ

PROTECTIVE FORTIFYING CREAM n
BROAD SPECTRUM
SPF 22
SUNSCREEN

12mL NET WT. .43 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: 58411-562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.2472 g  in 12 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.60564 g  in 12 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.618 g  in 12 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.2472 g  in 12 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)
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)
BEHENETH-20 (UNII: BJ4GP2IFLN)
PPG-17 (UNII: OV0Q322E0U)
DOCOSANOL (UNII: 9G1OE216XY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (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: 58411-562-10	1 in 1 CARTON	03/01/2020
1		12 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)