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 Factts

PURPOSE

• 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 mesaures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use  on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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 INGREDIENT

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 PALMAITATE  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

Shiseido

Ginza Tokyo

Ultimate

Sun Protection Lotion

50+

WetForce 

For Senstive Skin & Children

Broad Spectrum 

SPF 50+

For Face/Body

WATER RESISTAMT

(80 MINUTES)

SUNSCREEN

100 mL | 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: 58411-924
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.6116 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.6268 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 (1500 CST) (UNII: 4YI0729529)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
CYCLOMETHICONE (UNII: NMQ347994Z)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-6 (UNII: 5655G9Y8AQ)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG-32 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
RASPBERRY (UNII: 4N14V5R27W)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOSTEARIC ACID (UNII: X33R8U0062)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
TOCOPHEROL (UNII: R0ZB2556P8)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-924-10	1 in 1 CARTON	06/09/2027
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 Drug	M020	06/09/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-924) , analysis(58411-924)