SHISEIDO ULTIMATE SUN PROTECTION S- titanium dioxide and zinc oxide lotion

SHISEIDO ULTIMATE SUN PROTECTION S by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTION S 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
TITANIUM DIOXIDE 9.1%	Sunscreen
ZINC OXIDE 19.3%	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
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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

DIMETHICONE WATER BUTYLENE GLYCOL GLYCERIN DIISOPROPYL SEBACATE POLYMETHYL METHACRYLATE HYDROGENATED POLYDECENE PEG-10 DIMETHICONE CYCLOMETHICONE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 PEG-6 TRIMETHYLSILOXYSILICATE PEG-32 PEG/PPG-14/7 DIMETHYL ETHER SCUTELLARIA BAICALENSIS ROOT EXTRACT RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT ALOE BARBADENSIS LEAF EXTRACT THYMUS SERPILLUM EXTRACT ALUMINUM DISTEARATE ALUMINUM HYDROXIDE HYDROGEN DIMETHICONE ISOSTEARIC ACID DISTEARDIMONIUM HECTORITE HYDRATED SILICA SODIUM METAPHOSPHATE TRIETHOXYCAPRYLYLSILANE STEARIC ACID DEXTRIN PALMITATE DISTEARYLDIMONIUM CHLORIDE TOCOPHEROL SYZYGIUM JAMBOS LEAF EXTRACT

Other information

• protect this product in this container from excessive heat and direct sun.
• avoid contact with clothing and other textiles-may stain.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

SHI SEIDO

Anti-Aging Suncare

50+
WetForce
For Sensitive Skin
& Children

Ultimate
Sun Protection Lotion

BROAD SPECTRUM
SPF 50+

For Face/Body
WATER RESISTANT (80 MINUTES)
SUNSCREEN

100mL 3.3 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTION S 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.61 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.63 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
RASPBERRY (UNII: 4N14V5R27W)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOSTEARIC ACID (UNII: X33R8U0062)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-260-10	1 in 1 CARTON	02/01/2016
1		100 mL in 1 BOTTLE; 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	02/01/2016

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-260) , analysis(58411-260)