WELLAGE REAL HYALURONIC WATERY GLOW SUN SCREEN- avobenzone, homosalate, octisalate, octocrylene cream

Wellage Real Hyaluronic Watery Glow Sun Screen by

Drug Labeling and Warnings

Wellage Real Hyaluronic Watery Glow Sun Screen by is a Otc medication manufactured, distributed, or labeled by Hugel, Inc., COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.85 %

Homosalate 7 %

Octisalate 4.5 %

Octocrylene 9 %

Purpose

sunscreen

Uses

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 a Poison Control Center right away.

Directions

■ apply liberally 15 minutes before sun exposure.
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
■ reapply at least every 2 hours
■ use a water-resistant sunscreen if swimming or sweating

Other information

■ protect the product from excessive heat and 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.

Inactive ingredients

Water, Butylene Glycol, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Silica, 1,2-Hexanediol, Pentylene Glycol, Hydroxyethyl Urea, Cetearyl Olivate, Poly C10-30 Alkyl Acry- late, Sorbitan Olivate, Cetyl Alcohol, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Trometha- mine, Xanthan Gum, Ethylhexylglycerin, Glycerin, Hydrogenated Lecithin, Caprylic/Capric Trigly- ceride, Sodium Stearoyl Glutamate, Sucrose Laurate, Tocopherol, Arginine, Glycine, Histidine, Serine, Hydrolyzed Hyaluronic Acid, Lysolecithin, Benzyl Glycol, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Hyaluronate Cross- polymer, Hydroxypropyltrimonium Hyaluronate, Hyaluronic Acid, Sodium Acetylated Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELLAGE REAL HYALURONIC WATERY GLOW SUN SCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81165-001
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 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.425 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SILICA (UNII: ETJ7Z6XBU4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
SERINE (UNII: 452VLY9402)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SUCROSE LAURATE (UNII: 05Q7CD0E49)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
HYALURONIC ACID (UNII: S270N0TRQY)
TROMETHAMINE (UNII: 023C2WHX2V)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ARGININE (UNII: 94ZLA3W45F)
BENZYL GLYCOL (UNII: 06S8147L47)
WATER (UNII: 059QF0KO0R)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81165-001-03	2 in 1 BOX	06/22/2025
1	NDC: 81165-001-02	1 in 1 BOX
1	NDC: 81165-001-01	50 mL in 1 BOTTLE, PLASTIC; 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	06/22/2025

Labeler - Hugel, Inc. (695674672)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(81165-001)