21STAY A THERA SUN BLOCK- octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream

21STAY A Thera Sun Block by

Drug Labeling and Warnings

21STAY A Thera Sun Block by is a Otc medication manufactured, distributed, or labeled by Oracle Cosmetic Co., Ltd., COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.00%
Zinc Oxide 5.82%
Titanium Dioxide 5.46%
Octisalate 4.00%
Homosalate 2.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Ether, Polymethyl Methacrylate, Dimethicone, Silica, Disteardimonium Hectorite, Sodium Chloride, Aluminum Hydroxide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol, Polymethylsilsesquioxane, Stearic Acid, Fragrance, Phenoxyethanol, Dimethicone/Vinyl DimethiconeCrosspolymer, Sorbitan Sesquioleate, Dimethicone/Methicone Copolymer, Propanediol, Ethylhexylglycerin, Butylene Glycol, Octyldodecanol, Bambusa Vulgaris Extract, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum HalicacabumFlower/Leaf/Vine Extract, Lepidium Meyenii Root Extract, Vitis Vinifera (Grape) Seed Oil, Tocopherol, Vegetable Oil, Camellia Sinensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Maltodextrin

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

21STAY A THERA SUN BLOCK 
octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71883-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	58.2 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	54.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Dicaprylyl Ether (UNII: 77JZM5516Z)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CHIA SEED (UNII: NU0OLX06F8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
1,2-Hexanediol (UNII: TR046Y3K1G)
BEMOTRIZINOL (UNII: PWZ1720CBH)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
Stearic Acid (UNII: 4ELV7Z65AP)
Phenoxyethanol (UNII: HIE492ZZ3T)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
Butylene Glycol (UNII: 3XUS85K0RA)
Octyldodecanol (UNII: 461N1O614Y)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
LEPIDIUM MEYENII ROOT (UNII: HP7119212T)
GRAPE SEED OIL (UNII: 930MLC8XGG)
Tocopherol (UNII: R0ZB2556P8)
CORN OIL (UNII: 8470G57WFM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAGE (UNII: 065C5D077J)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
Maltodextrin (UNII: 7CVR7L4A2D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71883-001-02	1 in 1 CARTON	11/21/2017
1	NDC: 71883-001-01	40 mL in 1 CONTAINER; 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	11/21/2017

Labeler - Oracle Cosmetic Co., Ltd. (688258270)

Registrant - Oracle Cosmetic Co., Ltd. (688258270)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(71883-001)