SHISEIDO ULTIMATE SUN PROTECTOR- octisalate, octocrylene, zinc oxide cream

SHISEIDO ULTIMATE SUN PROTECTOR by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTOR 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

PURPOSE

Active ingredients	Purpose
Octisalate 3.0%	Sunscreen
Octocrylene 3.0%
Zinc Oxide 19.4%

Uses

• helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not useon damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctorif 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.

WARNINGS

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

Directions

• 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. - 2p.m.
• wear long-sleeve shirts, pant, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

WATER･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･PEG/PPG-9/2 DIMETHYL ETHER･GLYCERIN･ALCOHOL･PPG-3 DIPIVALATE･TALC･POLYGLYCERYL-6 POLYRICINOLEATE･SILICA･DEXTRIN PALMITATE･DEXTRIN PALMITATE/ETHYLHEXANOATE･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SODIUM HYALURONATE･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･HYDROGEN DIMETHICONE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･TOCOPHEROL･BHT･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･PEG-6･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･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

Principal Display Panel- 50mL Tube

SHISEIDO

GINZA TOKYO

Ultimate Sun Protector Cream

SPF 50

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES) 

SUNSCREEN

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTOR 
octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-971
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8105 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	1.8105 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.7079 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALCOHOL (UNII: 3K9958V90M)
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
SILICA (UNII: ETJ7Z6XBU4)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
AMINOETHANESULFINIC ACID (UNII: 5L08GE4332)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)
SUCCINOGLYCAN (AGROBACTERIUM TUMEFACIENS) (UNII: YP632MQS35)
TOCOPHEROL (UNII: R0ZB2556P8)
BHT (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-971-60	1 in 1 BOX	03/01/2025
1		50 mL in 1 TUBE; 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	03/01/2025

Labeler - Shiseido Americas Corporation (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	manufacture(58411-971) , analysis(58411-971)