Label: SILKEN PORE PERFECTING SUNSCREEN BROAD SPECTRUM SPF 35- octisalate, zinc oxide lotion
- NDC Code(s): 69417-150-03, 69417-150-20
- Packager: TATCHA INC.
- 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 June 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply 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
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, GLYCYRRHIZA INFLATA ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM, SERICIN, ALGAE EXTRACT, LECITHIN, INOSITOL, POLYHYDROXYSTEARIC ACID, SORBITAN TRISTEARATE, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, SILICA, POTASSIUM SORBATE, BEHENETH-20, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, POLYMETHYLSILSESQUIOXANE, METHICONE, TRIMETHYLSILOXYSILICATE, DIMETHICONOL, DISODIUM EDTA, FRAGRANCE, ETHYLHEXYLGLYCERIN, ALCOHOL, PHENOXYETHANOL, IRON OXIDES (CI77491), TIN OXIDE (CI 77861), MICA (CI 77019), TITANIUM DIOXIDE (CI 77891)
- Questions?
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SPL UNCLASSIFIED SECTION
PA +++
A weightless sunscreen that protects against UVA/UVB rays with SPF 35 and reduces the look of pores for a smooth, matte finish.
Formulated without parabens, synthetic fragrances, mineral oil, sulfate detergents, phthalates, urea, DEA or TEA.
Non-comedogenic.
Non-irritating.
Non-sensitizing.
Dermatologist tested.
FORMULATED IN JAPAN
MADE IN USA
DIST. TATCHA LLC
SAN FRANCISCO, CA 94123 USA
UK: DELPHIC HSE GU14 7NA
NL: 104 SCHIPHOL, 1118CN
© 2023 TATCHA LLC
TATCHA.COM
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- Packaging
-
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:69417-150 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 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 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) RHAPHIOLEPIS BIBAS LEAF (UNII: Z02066SV11) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) GLYCYRRHIZA INFLATA ROOT (UNII: 1MV1Z7MKVQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 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) SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) BEHENETH-20 (UNII: BJ4GP2IFLN) METHICONE (20 CST) (UNII: 6777U11MKT) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) STANNIC OXIDE (UNII: KM7N50LOS6) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69417-150-03 1 in 1 CARTON 04/26/2023 1 10 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69417-150-20 1 in 1 CARTON 04/26/2023 2 60 mL 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 04/26/2023 Labeler - TATCHA INC. (006811461)
