SHISEIDO ULTIMATE SUN PROTECTION PLUS- octinoxate, octocrylene, titanium dioxide, and zinc oxide lotion

SHISEIDO ULTIMATE SUN PROTECTION PLUS by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTION PLUS 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
OCTOCRYLENE 3.0%	Sunscreen
TITANIUM DIOXIDE 1.7%	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

WATER, DIMETHICONE, BUTYLENE GLYCOL, ISOPROPYL MYRISTATE, SD ALCOHOL 40-B, ISODODECANE, POLYMETHYL METHACRYLATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIMETHYLSILOXYSILICATE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, XYLITOL, GLYCERIN, METHYL GLUCETH-10, SAXIFRAGA SARMENTOSA EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, HYDROGENATED POLYDECENE, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, DISTEARDIMONIUM HECTORITE, SODIUM ACRYLOYLDIMETHYLTAURATE/METHACRYLAMIDOLAURIC ACID COPOLYMER, SILICA, ALUMINA, POLYMETHYLSILSESQUIOXANE, TALC, ALCOHOL, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

SHI SEIDO

Anti-Aging Suncare

50+

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 PLUS 
octinoxate, octocrylene, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-274
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8673 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3516 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1992 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.62 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ECTOINE (UNII: 7GXZ3858RY)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-274-10	1 in 1 CARTON	10/01/2012
1		100 mL in 1 BOTTLE, PLASTIC; 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	10/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-274) , analysis(52686-274)