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]

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. 

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: 69417-110
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: 69417-110-20	1 in 1 CARTON	06/01/2015
1		60 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)