AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK)- octocrylene, homosalate, octisalate, avobenzone cream

AGE20S UV Defense HYDRO CALMING SUNSCREEN(Twin pack) by

Drug Labeling and Warnings

AGE20S UV Defense HYDRO CALMING SUNSCREEN(Twin pack) by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 2.70%

Homosalate 7.00%

Octisalate 4.50%

Octocrylene 9.00%

PURPOSE

Sunscreen

INDICATIONS & USAGE

■ 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 skin 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 poison control center right away.

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

■ Protect the product in the container from excessive heat and avoid storing it under 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.

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

INGREDIENTS AND APPEARANCE

AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK) 
octocrylene, homosalate, octisalate, avobenzone cream

Product 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)