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

SILKEN pore perfecting sunscreen broad spectrum SPF 35 by

Drug Labeling and Warnings

SILKEN pore perfecting sunscreen broad spectrum SPF 35 by is a Otc medication manufactured, distributed, or labeled by TATCHA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octisalate 5%

Zinc Oxide 15%

Purpose

Sunscreen

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

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

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• 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.

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?

Call toll free (888) 739-2932 ext. 1

Call toll free (877) 322-8633

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 lotion

Product 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)