SHISEIDO ULTIMATE SUN PROTECTION- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray 
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SHISEIDO ULTIMATE SUN PROTECTION SPRAY

Drug Facts

Active ingredientsPurpose
AVOBENZONE 3.0%Sunscreen
HOMOSALATE 15.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 2.5%Sunscreen
OXYBENZONE 5.0%Sunscreen

Uses

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.

When using this product keep away from face to avoid breathing it.

Flammable

Do not use near heat, flame, or while smoking

Directions

For sunscreen use:

Inactive Ingredients

SD ALCOHOL 40-B, DIMETHICONE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BUTYLENE GLYCOL, XYLITOL, SYZYGIUM JAMBOS LEAF EXTRACT, PEG/PPG-14/7 DIMETHYL ETHER, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, WATER, FRAGRANCE,

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton

SHI SEIDO

Anti-Aging Suncare

50+

Ultimate
Sun Protection Spray

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

Principal Display Panel - 150 mL Bottle Carton
SHISEIDO ULTIMATE SUN PROTECTION 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.98 mg  in 132.6 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE19.89 mg  in 132.6 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE6.63 mg  in 132.6 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.32 mg  in 132.6 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6.63 mg  in 132.6 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
XYLITOL (UNII: VCQ006KQ1E)  
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-142-801 in 1 CARTON04/01/2014
1132.6 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2014
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-142) , analysis(58411-142)

Revised: 12/2018
Document Id: 7d6ab961-cc20-ef66-e053-2a91aa0a26e6
Set id: 6f1d6ce5-f12a-42db-9f9d-45b07a764974
Version: 3
Effective Time: 20181219
 
SHISEIDO AMERICAS CORPORATION