DEWYVITA ZERO SPOT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream

DewyVita Zero Spot Sunscreen by

Drug Labeling and Warnings

DewyVita Zero Spot Sunscreen by is a Otc medication manufactured, distributed, or labeled by reBom Co., Ltd., reBom Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octocrylene 9.00%

Homosalate 7.30%

Octisalate 4.90%

Avobenzone 2.90%

PURPOSE

Sunscreen

INDICATIONS & USAGE

■ Helps preven 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

Do not use ■ on damaged or broken skin.

WHEN USING

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

STOP USE

STOP USE

Stop use and ask a doctor if ■ rash occurs.

KEEP OUT OF REACH OF CHILDREN

■ keep out of reach of children.

DOSAGE & ADMINISTRATION

■ Apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

Water/Aqua, Butyloctyl Salicylate, Dipropylene Glycol, Silica, Nia cinamide, Diphenylsiloxy Phenyl Trimethicone, Sorbitan Olivate, Benzyl Glycol, Cetearyl Glucoside, Polymethylsilsesquioxane, Poly C10-30 Alkyl Acrylate, Dimethicone/Phenyl Vinyl Dimethicone Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Xanthan Gum, Cetearyl Alcohol, Ethylhexylglycerin, Adenosine, Centella Asiatica Extract, Rosa Damascena Flower Extract, Lactobacillus Ferment, Leontopodium Alpinum Callus Culture Extract, Butylene Glycol, Punica Granatum Fruit Extract, Madecassoside, 1,2-Hexanediol, Glycerin, Camellia Sinensis Leaf Water, Glutathione, Asiaticoside, Ethyl Hexanediol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Madecassic Acid, Sodium Hyaluronate, Asiatic Acid, Hyaluronic Acid, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Caprylyl Glycol, Sodium Hyaluronate DimethyIsilanol, Sodium Acetylated Hyaluronate

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DEWYVITA ZERO SPOT SUNSCREEN 
octocrylene, homosalate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60604-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.176 g  in 24 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	1.752 g  in 24 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.696 g  in 24 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.16 g  in 24 g

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICA (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)
ARGININE (UNII: 94ZLA3W45F)
ADENOSINE (UNII: K72T3FS567)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
GLUTATHIONE (UNII: GAN16C9B8O)
ASIATICOSIDE (UNII: PKO39VY215)
ETHYL HEXANEDIOL (UNII: M9JGK7U88V)
HYALURONIC ACID (UNII: S270N0TRQY)
MADECASSIC ACID (UNII: M7O1N24J82)
BENZYL GLYCOL (UNII: 06S8147L47)
DIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMER (UNII: ST6ZC4KVH2)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
PUNICA GRANATUM FRUIT JUICE (UNII: 99S671U9KB)
DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
ASIATIC ACID (UNII: 9PA5A687X5)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60604-501-02	1 in 1 CONTAINER	05/15/2025
1	NDC: 60604-501-01	50 g in 1 CASE; 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	05/15/2025

Labeler - reBom Co., Ltd. (695951708)

Establishment
Name	Address	ID/FEI	Business Operations
reBom Co., Ltd		695951708	manufacture(60604-501)