SHISEIDO WHITE LUCENT: Package Insert and Label Information

SHISEIDO WHITE LUCENT- ensulizole, octinoxate and titanium dioxide cream
SHISEIDO AMERICA INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

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.

Principal Display Panel -- 50 mL Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 1.275 g in 51 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.774 g in 51 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.969 g in 51 g
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52686-227-50 1 JAR in 1 CARTON contains a JAR
1 51 g in 1 JAR This package is contained within the CARTON (52686-227-50)
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 Operations
SHISEIDO AMERICA INC. 782677132 analysis (52686-227), manufacture (52686-227)

Revised: 12/2018 SHISEIDO AMERICA INC.

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