Label: COSRX- vitamin e vitalizing sunscreen lotion
- NDC Code(s): 70319-220-01
- Packager: COSRX inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 9, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WHEN USING
- WARNINGS
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DESCRIPTION
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.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COSRX
vitamin e vitalizing sunscreen lotionProduct 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)
