SHISEIDO ULTIMATE SUN PROTECTION PLUS- octinoxate, octocrylene, titanium dioxide, and zinc oxide cream 
SHISEIDO AMERICA INC.

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SHISEIDO ULTIMATE SUN PROTECTION

Cream+

Drug Facts

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, SD ALCOHOL 40-B, ISOHEXADECANE, BUTYLENE GLYCOL, DIMETHICONE, ISOPROPYL MYRISTATE, POLYMETHYL METHACRYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, XYLITOL, GLYCERIN, DISTEARDIMONIUM HECTORITE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, ISODODECANE, TRIMETHYLSILOXYSILICATE, PEG-6, PEG-32, SAXIFRAGA SARMENTOSA EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, HYDROGEN DIMETHICONE, SILICA, CARBOXYDECYL TRISILOXANE, TRISODIUM EDTA, SODIUM ACRYLOYLDIMETHYLTAURATE/METHACRYLAMIDOLAURIC ACID COPOLYMER, ALUMINA, POLYMETHYLSILSESQUIOXANE, TALC, ALCOHOL, 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

SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SHISEIDO

Anti-Aging Suncare

50+

Ultimate
Sun Protection
Cream+

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2.1 OZ.

Principal Display Panel - 50 mL Tube Carton
SHISEIDO ULTIMATE SUN PROTECTION PLUS 
octinoxate, octocrylene, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-273
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4503 g  in 60.85 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1826 g  in 60.85 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1034 mg  in 60.85 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.74 g  in 60.85 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISODODECANE (UNII: A8289P68Y2)  
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
ONONIS CAMPESTRIS ROOT (UNII: FD2FMC53M1)  
ECTOINE (UNII: 7GXZ3858RY)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
TALC (UNII: 7SEV7J4R1U)  
ALCOHOL (UNII: 3K9958V90M)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-273-601 in 1 CARTON10/01/201209/30/2017
160.85 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02010/01/201209/30/2017
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(52686-273) , analysis(52686-273)

Revised: 10/2023
Document Id: 75aec336-6ff2-4c72-b675-7ed7086e1da1
Set id: 272755ff-9bb1-48f6-9356-0d68cfa5c618
Version: 5
Effective Time: 20231017
 
SHISEIDO AMERICA INC.