SHISEIDO SUNCARE ULTIMATE- octinoxate, titanium dioxide, and zinc oxide cream

SHISEIDO SUNCARE ULTIMATE by

Drug Labeling and Warnings

SHISEIDO SUNCARE ULTIMATE 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
• OCTINOXATE 7.4%: Sunscreen
• TITANIUM DIOXIDE 2.2%: 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 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, POLYMETHYLSILSESQUIOXANE, PEG-10 DIMETHICONE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, DISTEARDIMONIUM HECTORITE, GLYCERIN, XYLITOL, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, HYDROGENATED POLYDECENE, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, STEARIC ACID, ACRYLATES/DIMETHICONE COPOLYMER, ISOSTEARIC ACID, TRISODIUM EDTA, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

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. 12627

www.shiseido.com

PRINCIPAL DISPLAY PANEL - 50mL Carton

SHISEIDO

Anti-Aging Suncare
UVA and UVB Protection

55
Ultimate
Sun Protection
Cream N

SPF 55PA+++

For Face

VERY WATER-RESISTANT

SUNSCREEN

50mL NET WT. 2 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO SUNCARE ULTIMATE 
octinoxate, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	4.218 g  in 57 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium - UNII:D1JT611TNE)	Titanium Dioxide	1.254 g  in 57 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS)	Zinc Oxide	9.291 g  in 57 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-225-60	1 in 1 CARTON
1		57 g in 1 TUBE

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, MANUFACTURE