Label: SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35- octisalate, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69417-110-03 - Packager: TATCHA INC.
- 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 26, 2018
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- Active Ingredients
- Uses
- Warnings
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35
octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69417-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69417-110-03 1 in 1 CARTON 06/01/2015 1 10 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 not final part352 06/01/2015 Labeler - TATCHA INC. (006811461)