ABIB DEWY TINTED SUNSCREEN GLOW TUBE MEDIUM- octisalate, octocrylene, zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Octisalate 4.50%
Octocrylene 5.00%
Zinc Oxide 13.1%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use(s)

■ 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

Warnings

■ For external use only.

■ Do not use on damaged or broken skin.

■ Stop use and ask a doctor if rash occurs

■ When using this product keep out of eyes. Rinse with water to remove.

■ Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

■ Apply liberally and evenly 15 minutes before sun exposure

■ Reapply at least every two 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

■ Children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

Other Information

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

QUESTIONS

Questions

■ contact@fourco.co.kr

INACTIVE INGREDIENT

Inactive ingredients

Water, Butylene Glycol, Butyloctyl Salicylate, Propanediol, Vinyl Dimethicone, Lauryl Dimethicone, Benzotriazolyl Dodecyl p-Cresol, 1,2-Hexanediol, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Poly C10-30 Alkyl Acrylate, Trimethyl Pentaphenyl Trisiloxane, Dipropylene Glycol, Polysorbate 60, Polymethylsilsesquioxane, Polyglyceryl-6 Stearate, Cetearyl Olivate, Polyacrylate-13, Acrylates Copolymer, Pentylene Glycol, Sorbitan Olivate, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, Hydrogenated Polyisobutene, Isododecane, Hydroxyacetophenone, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Citric Acid, Microcrystalline Cellulose, Ethylhexyl Palmitate, Sodium Citrate, Polyamide-8, Lecithin, Polyglyceryl-6 Behenate, Polyglyceryl-10 Laurate, Iron Oxides (CI 77491), Sphingomonas Ferment Extract, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethiconol, Isopropyl Myristate, Isostearic Acid, Iron Oxides (CI 77499), Sorbitan Isostearate, Polyglyceryl-3 Polyricinoleate, Cellulose Gum, Sodium Phytate, Biosaccharide Gum-1, Ethylhexylglycerin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Ectoin, Hyaluronic Acid, Niacinamide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ABIB DEWY TINTED SUNSCREEN GLOW TUBE MEDIUM 
octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73676-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	13.1 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIMETHYL PENTAPHENYL TRISILOXANE (UNII: HE7ABK56N5)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73676-220-02	1 in 1 CARTON	04/01/2026
1	NDC: 73676-220-01	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 Drug	M020	04/01/2026

Labeler - FOURCOMPANY CO., LTD. (694864584)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(73676-220)