Label: SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35- octisalate, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 30, 2019

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  • Active Ingredients

    Octisalate 5.00%

    Zinc Oxide 15.00%

  • Uses

    • Helps prevens sunburn
    • If used as direced with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun.
  • Warnings

    When using this product • keep out of eyes • rinse with water to remove • do not use on damaged or broken skin

    Stop use and ask a docor • if rash occurs

    Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

    For external use only

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use water resistant sunscreen if swimming or sweathing
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun especially from 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Inactive Ingredients

    WATER, ISODODECANE, CYCLOPENTASILOXANE, PROPANEDIOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, GLYCERIN, DIMETHICONE, OCTYLDODECYL NEOPENTANOATE, BEHENYL ALCOHOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ROSA MULTIFLORA FRUIT EXTRACT, ERIOBOTRYA JAPONICA LEAF EXTRACT, STEARYL GLYCYRRHETINATE (LICORICE EXTRACT), GLYCYRRHIZA INFLATA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM, SERICIN (SILK EXTRACT), ALGAE EXTRACT, LECITHIN, INOSITOL (RICE EXTRACT), POLYHYDROXYSTEARIC ACID, SORBITAN TRISTEARATE, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, SILICA, POTASSIUM SORBATE, BEHENETH-20, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, TITANIUM DIOXIDE, METHICONE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, DISODIUM EDTA, IRON OXIDES (CI77491), TIN OXIDE, MICA, FRAGRANCE (NATURAL), ETHYLHEXYLGLYCERIN, ALCOHOL, PHENOXYETHANOL.

  • Other Information

    • Protect this product form excessive heat and direct sun.
  • PRINCIPAL DISPLAY PANEL

    TATCHA 

    SILKEN 

    pore perfecting sunscreen

    broad spectrum SPF 35 

    PA +++

    Japanese wild rose and silk extracts

    and Hadasei-3TM Complex 

    60 ml| 2 fl. oz. 

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35 
    octisalate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69417-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)  
    ERIOBOTRYA JAPONICA LEAF (UNII: Z02066SV11)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    GLYCYRRHIZA ECHINATA ROOT (UNII: V6E722P1VB)  
    CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    SILK SERICIN (UNII: 0N1VMU8G9W)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INOSITOL (UNII: 4L6452S749)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BEHENETH-20 (UNII: BJ4GP2IFLN)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    MICA (UNII: V8A1AW0880)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69417-110-201 in 1 CARTON06/01/2015
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2015
    Labeler - TATCHA INC. (006811461)
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