SHISEIDO SUNCARE ULTIMATE: Package Insert and Label Information

SHISEIDO SUNCARE ULTIMATE- ensulizole, octinoxate and zinc oxide lotion
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 2.0% Sunscreen
OCTINOXATE 7.4% Sunscreen
ZINC OXIDE 16.3% Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

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 generously to face and body before sun exposure.
  • children under 6 months of age: ask a doctor.
  • reapply as needed or after towel drying, swimming or perspiring.

Other information

  • high sun protection product.
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Inactive ingredients

CYCLOMETHICONE, WATER, BUTYLENE GLYCOL, DIMETHICONE, CETYL ETHYLHEXANOATE, POLYMETHYLSILSESQUIOXANE, SD ALCOHOL 40-B, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, OCTORYLENE, TRIMETHYLSILOXYSILICATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHANOLAMINE, GLYCERIN, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, ISOSTEARIC ACID, ACRYLATES/DIMETHICONE COPOLYMER, TRISODIUM EDTA, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

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. 12628

www.shiseido.com

PRINCIPAL DISPLAY PANEL — 100 mL Carton

SHISEIDO

Anti-Aging Suncare
UVA and UVB Protection

60

Ultimate
Sun Protection Lotion N

SPF 60 • PA+++

For Face/Body

VERY WATER-RESISTANT

SUNSCREEN

100mL 3.3 FL. OZ.

Principal Display Panel -- 100 mL Carton
(click image for full-size original)
SHISEIDO SUNCARE ULTIMATE
ensulizole, octinoxate, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-226
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ensulizole (Ensulizole) Ensulizole 1.88 g in 94 g
Octinoxate (Octinoxate) Octinoxate 6.956 g in 94 g
Zinc Oxide (Zinc) Zinc Oxide 15.322 g in 94 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52686-226-10 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 94 g in 1 BOTTLE, PLASTIC This package is contained within the CARTON (52686-226-10)
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, MANUFACTURE

Revised: 01/2010 SHISEIDO AMERICA INC.

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