SHISEIDO ULTIMATE SUN PROTECTOR MINERAL- titanium dioxide and zinc oxide lotion

SHISEIDO ULTIMATE SUN PROTECTOR MINERAL by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTOR MINERAL 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 5.7%	Sunscreen
ZINC OXIDE 5.9%	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 useon damaged or broken skin

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

Stop use and ask a doctorif 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
• use a water resistant sunscreen if swimming or sweating
• reapply 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

WATER･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIMETHICONE･CETYL ETHYLHEXANOATE･TRISILOXANE･DIPROPYLENE GLYCOL･GLYCERIN･BUTYLOCTYL SALICYLATE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SILICA･PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･PEG-10 DIMETHICONE･DEXTRIN PALMITATE･MYRISTYL MYRISTATE･PHENETHYL BENZOATE･PEG/PPG-14/7 DIMETHYL ETHER･DIPOTASSIUM GLYCYRRHIZATE･SCUTELLARIA BAICALENSIS ROOT EXTRACT･HIBISCUS SABDARIFFA FLOWER EXTRACT･CITRUS DEPRESSA PEEL EXTRACT･RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT･HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT･ALOE BARBADENSIS LEAF EXTRACT･THYMUS SERPYLLUM EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･ALUMINUM HYDROXIDE･BUTYLENE GLYCOL･DISTEARDIMONIUM HECTORITE･HYDROGEN DIMETHICONE･ISOSTEARIC ACID･TRISODIUM EDTA･CALOPHYLLUM INOPHYLLUM SEED OIL･TRIETHOXYCAPRYLYLSILANE･SODIUM CITRATE･CITRIC ACID･STEARIC ACID･SODIUM METABISULFITE･GLUCOSYLRUTIN･SYZYGIUM JAMBOS LEAF EXTRACT･TOCOPHEROL･PHENOXYETHANOL･

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Container Carton

SHISEIDO
GINZA TOKYO

Ultimate Sun Protector
Lotion MINERAL

SPF
60+

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 60+
WATER RESISTANT (80 MINUTES)
SUNSCREEN

For All Skin Types Including Sensitive

150mL 5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTOR MINERAL 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-903
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.44 g  in 150 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.77 g  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
TRISILOXANE (UNII: 9G1ZW13R0G)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
TANGERINE PEEL (UNII: JU3D414057)
RASPBERRY (UNII: 4N14V5R27W)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE TRISODIUM (UNII: 420IP921MB)
CALOPHYLLUM INOPHYLLUM WHOLE (UNII: 7BHF8MMF6F)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MONOSODIUM CITRATE (UNII: 68538UP9SE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-903-40	1 in 1 CARTON	01/01/2025
1		150 mL in 1 CONTAINER; 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	01/01/2025

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	analysis(58411-903) , manufacture(58411-903)