COSRX by COSRX inc.

COSRX by

Drug Labeling and Warnings

COSRX by is a Otc medication manufactured, distributed, or labeled by COSRX inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COSRX- vitamin e vitalizing sunscreen lotion 
COSRX inc.

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.

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Avobenzone 2.5%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene 9.0%

Sunscreen

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.

For external use only

Do not use on damanged 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 swallowed, get medical help or contact a Poison Control Center right away.

Apply liberally 15 minutes before sun exposure
Children under 6 months of age : Ask a doctor.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
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 value 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-sleeved shirts, pants, hats, and sunglasses.

Protect the product in this container from excessive heat and direct sun.
Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Water / Aqua / Eau, Propanediol, Butyloctyl salicylate, Diphenylsiloxy phenyl trimethicone, Dimethicone, VP/Eicosene copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 alcohols, Cetyl alcohol, Potassium cetyl phosphate, Polyacrylate-13, Polyisobutene, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol

global@cosrx.co.kr

Vitamin E

Vitalizing Sunscreen

Tocopherol

SPF 50+ sunscreen contains Vitamin E

to protect your skin from light (UV rays)

and heat (Aging signs) leaving your

skin healthy and moisturized.

SPF50+ BROAD SPECTRUM

50mL /1.69 fl. oz.

COSRX

COSRX 
vitamin e vitalizing sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70319-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.5 mg  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.25 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.25 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.65 mg  in 50 mL
TRISILOXANE (UNII: 9G1ZW13R0G)	0.6 mg  in 50 mL
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	0.5 mg  in 50 mL
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)	0.5 mg  in 50 mL
PEG-100 STEARATE (UNII: YD01N1999R)	0.325 mg  in 50 mL
CETYL ALCOHOL (UNII: 936JST6JCN)	0.25 mg  in 50 mL
CETETH-18 (UNII: 9E0067TYQH)	0.0075 mg  in 50 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	0.04 mg  in 50 mL
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)	1 mg  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O)	0.9 mg  in 50 mL
ECHINACEA PURPUREA FLOWERING TOP WATER (UNII: G72P70SL42)	22.26195 mg  in 50 mL
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)	0.0008 mg  in 50 mL
1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)	5 mg  in 50 mL
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)	0.85 mg  in 50 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.5 mg  in 50 mL
DOCOSANOL (UNII: 9G1OE216XY)	0.35 mg  in 50 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)	0.325 mg  in 50 mL
C14-22 ALCOHOLS (UNII: B1K89384RJ)	0.318 mg  in 50 mL
POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31)	0.108 mg  in 50 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.025 mg  in 50 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.024975 mg  in 50 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.018 mg  in 50 mL
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)	0.016 mg  in 50 mL
COCOA (UNII: D9108TZ9KG)	0.0075 mg  in 50 mL
LEVANT COTTON SEED (UNII: 550E4N439V)	0.00225 mg  in 50 mL
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)	0.000025 mg  in 50 mL
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)	0.25 mg  in 50 mL
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)	0.1 mg  in 50 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70319-220-01	1 in 1 CARTON	01/09/2023
1		50 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 not final	part352	06/01/2022

Labeler - COSRX inc. (689516893)

Registrant - COSRX inc. (689516893)

Revised: 1/2023

Document Id: ef5c4400-5bc5-9a6d-e053-2a95a90a93eb

34390-5

Set id: daf0291e-770c-eaf2-e053-2a95a90a0b67

Version: 3

Effective Time: 20230109

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