CLE DE PEAU BEAUTE HAND- avobenzone, octinoxate, and octocrylene cream

CLE DE PEAU BEAUTE HAND by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE HAND 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 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∙BUTYLENE GLYCOL∙GLYCERIN∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙ISOHEXADECANE∙BEHENYL ALCOHOL∙TRIISOSTEARIN∙MYRISTYL MYRISTATE∙DIMETHICONE∙PEG/PPG-14/7 DIMETHYL ETHER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙SILICA∙TREHALOSE∙POTASSIUM METHOXYSALICYLATE∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙CAMELLIA JAPONICA SEED OIL∙POLYQUATERNIUM-51∙ROSA DAMASCENA FLOWER WATER∙SODIUM ACETYLATED HYALURONATE∙DIPOTASSIUM GLYCYRRHIZATE∙PRUNUS SPECIOSA LEAF EXTRACT∙PAEONIA SUFFRUTICOSA ROOT EXTRACT∙OLEA EUROPAEA (OLIVE) LEAF EXTRACT∙AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT∙2-O-ETHYL ASCORBIC ACID∙ROSE EXTRACT∙BUPLEURUM FALCATUM ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙STEARYL ALCOHOL∙BEHENETH-20∙SUCCINOGLYCAN∙TRISODIUM EDTA∙SODIUM CITRATE∙ALCOHOL∙SODIUM METAPHOSPHATE∙CITRIC ACID∙BHT∙SODIUM METABISULFITE∙ALUMINA∙TOCOPHEROL∙PHENOXYETHANOL∙FRAGRANCE∙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 - 75 mL Tube Carton

clé de peau
B E A U T É

hand cream

BROAD SPECTRUM
SPF 18
SUNSCREEN

18

75mL NET WT. 2.6 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE HAND 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1191 mg  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5656 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1529 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
DOCOSANOL (UNII: 9G1OE216XY)
TRIISOSTEARIN (UNII: 71503RH8KG)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BEHENETH-20 (UNII: BJ4GP2IFLN)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-236-60	1 in 1 CARTON	11/01/2014
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-236) , analysis(58411-236)