SHISEIDO WHITE LUCENT- ensulizole, octinoxate, and titanium dioxide cream

SHISEIDO WHITE LUCENT by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• ENSULIZOLE 2.5%: Sunscreen
• OCTINOXATE 7.4%: Sunscreen
• TITANIUM DIOXIDE 1.9%: Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply smoothly to face before sun exposure and as needed.
• children under 6 months of age: ask a doctor.

Inactive ingredients

WATER, BUTYLENE GLYCOL, GLYCERIN, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, PENTAERYTHRITYL TETRAETHYLHEXANOATE, DIMETHICONE, SD ALCOHOL 40-B, BEHENYL ALCOHOL, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRANEXAMIC ACID, BEHENETH-20, TRIETHANOLAMINE, SILICA, XANTHAN GUM, PEG/PPG-14/7 DIMETHYL ETHER, ERYTHRITOL, PEG/PPG-17/4 DIMETHYL ETHER, 2-O-ETHYL ASCORBIC ACID, GLUCOSYL HESPERIDIN, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, SODIUM HYALURONATE, STEARYL ALCOHOL, HYDROGENATED PALM OIL, ELAEIS GUINEENSIS (PALM) KERNEL OIL, ELAEIS GUINEENSIS (PALM) OIL, SODIUM METAPHOSPHATE, TRISODIUM EDTA, CELLULOSE GUM, ALUMINUM HYDROXIDE, BHT, SODIUM METABISULFITE, TOCOPHEROL, CITRIC ACID, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES

Questions?

1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
MADE IN U.S.A.
SHISEIDO DIST. NEW YORK PARIS MILANO
GLO. 10394

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 50 mL Carton

SHISEIDO

WHITE LUCENT

Brightening
Protective Cream w
SPF 15 PA++
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT 
ensulizole, octinoxate, and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.275 g  in 51 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.774 g  in 51 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.969 g  in 51 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-227-50	1 in 1 CARTON	02/01/2010
1		51 g in 1 JAR; 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	02/01/2010

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	analysis(52686-227) , manufacture(52686-227)