CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED N- avobenzone, octinoxate, and octocrylene emulsion

cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n by

Drug Labeling and Warnings

cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED 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 2.5%	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 useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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

WATERGLYCERINBUTYLENE GLYCOLDIPROPYLENE GLYCOLPENTAERYTHRITYL TETRAETHYLHEXANOATEDIPHENYLSILOXY PHENYL TRIMETHICONEBEHENYL ALCOHOLGLYCERYL DIISOSTEARATEBEHENETH-20XYLITOLSILICABETAINEDIMETHICONESD ALCOHOL 40-BPEG/PPG-14/7 DIMETHYL ETHERXANTHAN GUMTOCOPHERYL ACETATEPOLYQUATERNIUM-51DIPEPTIDE-15ERYTHRITOLPEG/PPG-17/4 DIMETHYL ETHERLAURYL BETAINECENTAUREA CYANUS FLOWER EXTRACTLAMIUM ALBUM FLOWER/LEAF/STEM EXTRACTMORUS ALBA ROOD EXTRACTSODIUM ACETYLATED HYALURONATESODIUM HYALURONATEMELISSA OFFICINALIS LEAF EXTRACTLECITHINNUPHAR JAPONICUM ROOT EXTRACTZINGIBER AROMATICUS EXTRACTPANAX GINSENG ROOT EXTRACTCAMELLIA SINENSIS LEAF EXTRACTGINKGO BILOBA LEAF EXTRACTBUPLEURUM FALCATUM ROOT EXTRACTPPG-17STEARYL ALCOHOLMYRISTYL MYRISTATEALCOHOLCARBOMERPOTASSIUM HYDROXIDEISOSTEARIC ACIDSODIUM METAPHOSPHATEDISODIUM EDTABHTSODIUM METABISULFITECINNAMOMUM CASSIA BARK EXTRACTTOCOPHEROLPHENOXYETHANOLMETHYLPARABENSODIUM BENZOATEFRAGRANCEIRON 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 - 20 mL Bottle Carton

SYNACTIF

Daytime
moisturizer
enriched

BROAD SPECTRUM
SPF 19
SUNSCREEN

clé de peau
BEAUTÉ

20mL NET WT. .7 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED N 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-889
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 mg  in 200 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	14.8 mg  in 200 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 mg  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
BEHENETH-20 (UNII: BJ4GP2IFLN)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BETAINE (UNII: 3SCV180C9W)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIGLYCINE (UNII: 10525P22U0)
ERYTHRITOL (UNII: RA96B954X6)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
LAURYL BETAINE (UNII: Y4P927Q133)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
LAMIUM ALBUM FLOWER (UNII: 62IB9494JA)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
NUPHAR JAPONICA ROOT (UNII: 3OPM78C6RQ)
GINGER (UNII: C5529G5JPQ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GINKGO (UNII: 19FUJ2C58T)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PPG-17 (UNII: OV0Q322E0U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHINESE CINNAMON (UNII: WS4CQ062KM)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FRAGRANCE 13576 (UNII: 5EM498GW35)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-889-40	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2024

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-889) , manufacture(58411-889)