SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS- avobenzone, homosalate, octisalate, and octocrylene stick 
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 CLEAR SUNSCREEN STICK SPF 50+

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
HOMOSALATE 10.0%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 10.0%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.

Directions

For sunscreen use:

Inactive Ingredients

DIPHENYLSILOXY PHENYL TRIMETHICONE▪MINERAL OIL▪HYDROXYSTEARIC ACID▪TRIETHYLHEXANOIN▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪DIBUTYL LAUROYL GLUTAMIDE▪C12-15 ALKYL BENZOATE▪POLYAMIDE-8▪SILICA DIMETHYL SILYLATE▪TOCOPHERYL ACETATE▪PEG/PPG-14/7 DIMETHYL ETHER▪LECITHIN▪GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT▪PPG-17▪CASTOR OIL/IPDI COPOLYMER▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪BHT▪TOCOPHEROL▪PEG-6▪PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE▪SILICA▪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 - 20 g Stick Pouch Label

SHISEIDO
GINZA TOKYO

Clear Sunscreen Stick
50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+
For Face/Body
WATER RESISTANT
(80 MINUTES)
SUNSCREEN

BIO

RE
USE

20g NET WT. .7 OZ.

PRINCIPAL DISPLAY PANEL - 20 g Stick Pouch Label
SHISEIDO CLEAR SUNSCREEN SPF 50 PLUS 
avobenzone, homosalate, octisalate, and octocrylene stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-616
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE500 mg  in 20 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2000 mg  in 20 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1000 mg  in 20 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2000 mg  in 20 g
Inactive Ingredients
Ingredient NameStrength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
MINERAL OIL (UNII: T5L8T28FGP)  
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
PEG/PPG-9/2 DIMETHYL ETHER (UNII: LM6Q66468X)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
PPG-17 (UNII: OV0Q322E0U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-616-201 in 1 POUCH01/01/2021
120 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2021
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 11/2020
Document Id: e20c68a1-9762-4287-a1e6-001c39639ccf
Set id: 15a786f2-2939-4aa2-a413-b661ff6d2dd9
Version: 1
Effective Time: 20201118
 
SHISEIDO AMERICAS CORPORATION