SHISEIDO CLEAR STICK UV PROTECTOR- avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone cream 
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 STICK UV PROTECTOR

Drug Facts

Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
HOMOSALATE 10.0%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTISALATE 5.0%Sunscreen
OCTOCRYLENE 5.0%Sunscreen
OXYBENZONE 3.0%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∙TRIETHYLHEXANOIN∙MINERAL OIL∙HYDROXYSTEARIC ACID∙DIBUTYL LAUROYL GLUTAMIDE∙POLYAMIDE-8∙PEG/PPG-14/7 DIMETHYL ETHER∙LECITHIN∙GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT∙PPG-17∙SILICA DIMETHYL SILYLATE∙BHT∙TOCOPHEROL∙PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE∙FRAGRANCE∙

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

SHI SEIDO
GINZA TOKYO

Clear Stick
UV Protector

50+
WetForce

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

15g NET WT. .52 OZ.

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
SHISEIDO CLEAR STICK UV PROTECTOR 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-365
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE375 mg  in 15 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1500 mg  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE735 mg  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE750 mg  in 15 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE750 mg  in 15 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE450 mg  in 15 g
Inactive Ingredients
Ingredient NameStrength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
MINERAL OIL (UNII: T5L8T28FGP)  
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
PPG-17 (UNII: OV0Q322E0U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-365-401 in 1 CARTON02/01/2018
115 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2018
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-365) , analysis(58411-365)

Revised: 12/2018
Document Id: 7cf2da9e-b031-d215-e053-2a91aa0a549e
Set id: be9d4fe9-8c31-4e6a-8ffc-030b3b72b481
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION