Label: SHISEIDO CLEAR STICK UV PROTECTOR- avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone cream
- NDC Code(s): 58411-365-40
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 13, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
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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
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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
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- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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INGREDIENTS AND APPEARANCE
SHISEIDO CLEAR STICK UV PROTECTOR
avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-365 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 375 mg in 15 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1500 mg in 15 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 735 mg in 15 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 750 mg in 15 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 750 mg in 15 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 450 mg in 15 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-365-40 1 in 1 CARTON 02/01/2018 1 15 g 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 final part352 02/01/2018 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-365) , analysis(58411-365)
