CLE DE PEAU BEAUTE PROTECTIVE DAY- avobenzone, octinoxate, octocrylene emulsion

cle de peau BEAUTE Protective Day by

Drug Labeling and Warnings

cle de peau BEAUTE Protective Day 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

PURPOSE

• Drug Facts: Purpose
• Avobenzone 2.5%: Sunscreen
• Octinoxate 4.9%: Sunscreen
• Octocrylene 5.0%: Sunscreen

INDICATIONS & USAGE

• 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

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. 

DOSAGE & ADMINISTRATION

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 INGREDIENT

WATER･DIPROPYLENE GLYCOL･BUTYLENE GLYCOL･ALCOHOL DENAT.･GLYCERIN･DIISOPROPYL SEBACATE･C12-15 ALKYL BENZOATE･SILICA･DIGLYCERIN･DIMETHICONE･TREHALOSE･POTASSIUM METHOXYSALICYLATE･PHYTOSTERYL MACADAMIATE･PEG-6･PEG-32･ORYZANOL･TOCOPHERYL ACETATE･PEG/PPG-17/4 DIMETHYL ETHER･TRIMETHYLSILOXYSILICATE･GINKGO BILOBA LEAF EXTRACT･CRATAEGUS MONOGYNA FLOWER EXTRACT･PANAX GINSENG ROOT EXTRACT･ONONIS SPINOSA ROOT EXTRACT･HYDRANGEA SERRATA LEAF EXTRACT･ROSA CANINA FRUIT EXTRACT･SAXIFRAGA SARMENTOSA EXTRACT･ZANTHOXYLUM PIPERITUM PEEL EXTRACT･HIBISCUS ESCULENTUS FRUIT EXTRACT･SODIUM ACETYLATED HYALURONATE･ROSA ROXBURGHII FRUIT EXTRACT･LILIUM CANDIDUM FLOWER EXTRACT･BUPLEURUM FALCATUM ROOT EXTRACT･PETROLATUM･HYDROGENATED POLYDECENE･PEG-10 PHYTOSTEROL･SUCCINOGLYCAN･MICA･PEG-6 DISTEARATE･BEHENETH-10･CARBOMER･ALCOHOL･PEG/PPG-19/19 DIMETHICONE･STEARIC ACID･DEXTRIN PALMITATE/ETHYLHEXANOATE･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･CERAMIDE NP･POTASSIUM HYDROXIDE･C13-16 ISOPARAFFIN･BHT･SODIUM METAPHOSPHATE･DISODIUM EDTA･C10-13 ISOPARAFFIN･SODIUM METABISULFITE･TOCOPHEROL･PHENOXYETHANOL･FRAGRANCE･TITANIUM DIOXIDE･IRON OXIDES･RED 33･YELLOW 5･

Other Information

• protect this product in this container from excessive heat and direct sunlight

Questions or Comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton 

clé de peau

BEAUTÉ

PROTECTIVE DAY

EMULSION

BROAD SPECTRUM

SPF 25

SUNSCREEN

125mL 4.2 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE PROTECTIVE DAY 
avobenzone, octinoxate, octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-953
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.25 g  in 125 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.38 g  in 125 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.51 g  in 125 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SILICA (UNII: ETJ7Z6XBU4)
DIGLYCERIN (UNII: 3YC120743U)
DIMETHICONE (UNII: 92RU3N3Y1O)
TREHALOSE (UNII: B8WCK70T7I)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
PEG-6 (UNII: 5655G9Y8AQ)
PEG-32 (UNII: 1212Z7S33A)
ORYZANOL (UNII: SST9XCL51M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
PANAX GINSENG ROOT (UNII: CUQ3A77YXI)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
HYDRANGEA SERRATA LEAF (UNII: 2SFZ1X3QA9)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
HIBISCUS ESCULENTUS SEED EXTRACT (UNII: 525G687TQW)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
SUCCINOGLYCAN (AGROBACTERIUM TUMEFACIENS) (UNII: YP632MQS35)
MICA (UNII: V8A1AW0880)
PEG-6 DISTEARATE (UNII: 8CU46UJ38C)
BEHENETH-10 (UNII: 313S43DM16)
CARBOMER (UNII: 0A5MM307FC)
ALCOHOL (UNII: 3K9958V90M)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
STEARIC ACID (UNII: 4ELV7Z65AP)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-953-10	1 in 1 BOX	12/11/2027
1		125 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/11/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-953) , analysis(58411-953)