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NDC 69417-0130-17 TATCHA THE SILK SUNSCREEN 100 mg/mL Details

TATCHA THE SILK SUNSCREEN 100 mg/mL

TATCHA THE SILK SUNSCREEN is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TATCHA INC.. The primary component is ZINC OXIDE.

Product Information

NDC	69417-0130
Product ID	69417-130_7af8271a-4ca7-4c83-ae75-af76d10eb53e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TATCHA THE SILK SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	ZINC OXIDE
Labeler Name	TATCHA INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69417-0130-17 (69417013017)

Pricing Information	N/A
NDC Package Code	69417-130-17
Billing NDC	69417013017
Package	1 BOTTLE in 1 BOX (69417-130-17) / 50 mL in 1 BOTTLE
Marketing Start Date	2022-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7799042a-d2de-480e-a8a3-827b3dc27907 Details

Drug Facts

Active Ingredient

Zinc Oxide (10%)

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

• Shake well.

• 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

AQUA/WATER/EAU, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAURYL PEG-8 DIMETHICONE, DIMETHICONE, ISODODECANE, TRIDECYL SALICYLATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PROPANEDIOL, CAPRYLYL METHICONE, POLYMETHYLSILSESQUIOXANE, NIACINAMIDE, SACCHAROMYCES/RICE FERMENT FILTRATE, SILICA, SQUALANE, CAMELLIA SINENSIS LEAF EXTRACT, CLADOSIPHON OKAMURANUS EXTRACT, HYDROLYZED SILK, BISABOLOL, ALLANTOIN, TOCOPHEROL, THEOBROMA CACAO (COCOA) SEED EXTRACT, ARCTIUM LAPPA ROOT EXTRACT, KAPPAPHYCUS ALVAREZII EXTRACT, SODIUM HYALURONATE, LECITHIN, CAESALPINIA SPINOSA FRUIT EXTRACT, LACTOBACILLUS, MALTODEXTRIN, CAPRYLYL GLYCOL, DIMETHICONE CROSSPOLYMER, HYDROGENATED LECITHIN, TETRASODIUM GLUTAMATE DIACETATE, PEG-10, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, PROPYLENE GLYCOL, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL, PHOSPHORIC ACID, SODIUM HYDROXIDE, SODIUM CHLORIDE, HEXYLENE GLYCOL, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, 77492, 77499)

Questions?

Call toll-free (877) 322-8633

SPL UNCLASSIFIED SECTION

broad spectrum SPF 50

PA ++++

HYDRATING MINERAL SHIELD

10% zinc oxide protects against UVA/UVB rays. Natural plant extracts and red algae cocoon skin from pollution and blue light. Silk primes skin, hyaluronic acid hydrates, and niacinamide evens tone. Leaves a healthy glow, never a white cast.

BEAUTIFUL FACES, BEAUTIFUL FUTURES

Your purchase supports education equality

www.tatcha.com/giving-back

MADE IN USA

Packaging

INGREDIENTS AND APPEARANCE

TATCHA THE SILK SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69417-130
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
NIACINAMIDE (UNII: 25X51I8RD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CLADOSIPHON OKAMURANUS (UNII: 2IJE0CH09J)
SILK, BASE HYDROLYZED (1000 MW) (UNII: UMQ31C11AY)
LEVOMENOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA (UNII: D9108TZ9KG)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
LACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69417-130-05	1 in 1 BOX	03/08/2022
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69417-130-17	1 in 1 BOX	03/08/2022
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/08/2022

Labeler - TATCHA INC. (006811461)

Revised: 3/2022

Document Id: 7af8271a-4ca7-4c83-ae75-af76d10eb53e

Set id: 7799042a-d2de-480e-a8a3-827b3dc27907

Version: 1

Effective Time: 20220328