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

SHISEIDO ULTIMATE SUN PROTECTION by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTION 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
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
TITANIUM DIOXIDE 1.4%	Sunscreen
ZINC OXIDE 16.4%	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.

Flammable. Do not use near heat, or while smoking.

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

WATERDIMETHICONESD ALCOHOL 40-BISOHEXADECANEBUTYLENE GLYCOLISOPROPYL MYRISTATEMETHYL METHACRYLATE CROSSPOLYMERLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEXYLITOLGLYCERINPOLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMERISODODECANETRIMETHYLSILOXYSILICATEDISTEARDIMONIUM HECTORITEPEG-6DEXTRIN PALMITATEPEG-32PEG/PPG-14/7 DIMETHYL ETHERSAXIFRAGA SARMENTOSA EXTRACTSCUTELLARIA BAICALENSIS ROOT EXTRACTONONIS SPINOSA ROOT EXTRACTECTOINSOPHORA ANGUSTIFOLIA ROOT EXTRACTSILICAHYDROGEN DIMETHICONECARBOXYDECYL TRISILOXANEALUMINUM HYDROXIDESTEARIC ACIDTRISODIUM EDTAPOLYMETHYLSILSESQUIOXANETALCALCOHOLBHTSYZYGIUM JAMBOS LEAF EXTRACTTOCOPHEROLPHENOXYETHANOLFRAGRANCE

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 - 50 mL Tube Carton

SHI SEIDO
GINZA TOKYO

Ultimate
Sun Protection Cream

50+
WetForce

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTION 
octinoxate, octocrylene, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4255 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1725 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	805 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9430 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOHEXADECANE (UNII: 918X1OUF1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
ECTOINE (UNII: 7GXZ3858RY)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
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: 58411-254-60	1 in 1 CARTON	02/01/2015
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58411-254-61	1 in 1 CARTON	02/01/2015
2		30 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 58411-254-62	1 in 1 CARTON	02/01/2015
3		15 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 58411-254-80	2 mL in 1 POUCH; Type 0: Not a Combination Product	02/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-254) , analysis(58411-254)