Label: AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK)- octocrylene, homosalate, octisalate, avobenzone cream
- NDC Code(s): 67225-5034-1, 67225-5034-2
- Packager: Aekyung Industrial Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 14, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Water, Propanediol, Butyloctyl Salicylate, Polyglyceryl-3 Distearate, Silica, Microcrystalline Cellulose, C13-15 Alkane, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Polyglycerin-3, Poly C10-30 Alkyl Acrylate, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Benzotriazolyl Dodecyl p-Cresol, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Butylene Glycol, Allantoin, Ammonium Polyacryloyldimethyl Taurate, Cetearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glycerin, Disodium EDTA, Oleic Acid, Caprylhydroxamic Acid, Ethanol, Cellulose Gum, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalenesis Root Extract, Tris(Tetramethylhy- droxypiperidinol) Citrate, t-Butyl Alcohol, Ascorbic Acid, Niacinamide, Tocopheryl Acetate, Saccharomyces Cerevisiae Extract, Hyaluronic Acid, Ceramide NP
- OTHER SAFETY INFORMATION
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DOSAGE & ADMINISTRATION
Directions
■ 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. Todecrease 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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK)
octocrylene, homosalate, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67225-5034 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3.5 g in 50 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.25 g in 50 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.35 g in 50 g Inactive Ingredients Ingredient Name Strength SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPANEDIOL (UNII: 5965N8W85T) EDETATE DISODIUM (UNII: 7FLD91C86K) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) HYALURONIC ACID (UNII: S270N0TRQY) GLYCERIN (UNII: PDC6A3C0OX) CERAMIDE NP (UNII: 4370DF050B) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALCOHOL (UNII: 3K9958V90M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) RICE BRAN (UNII: R60QEP13IC) PANTHENOL (UNII: WV9CM0O67Z) NIACINAMIDE (UNII: 25X51I8RD4) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y) DIPROPYLENE GLYCOL (UNII: E107L85C40) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALLANTOIN (UNII: 344S277G0Z) ASCORBIC ACID (UNII: PQ6CK8PD0R) WATER (UNII: 059QF0KO0R) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) OLEIC ACID (UNII: 2UMI9U37CP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) C13-15 ALKANE (UNII: 114P5I43UJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67225-5034-2 2 in 1 BOX 08/14/2024 1 NDC:67225-5034-1 50 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 Drug M020 08/14/2024 Labeler - Aekyung Industrial Co., Ltd. (690511126) Establishment Name Address ID/FEI Business Operations Aekyung Industrial Co., Ltd. 690511126 manufacture(67225-5034)