MEDIHEAL MADECASSOSIDE MOISTURE SUN SERUM- homosalate, octocrylene, octisalate, ensulizole lotion

Drug Labeling and Warnings

Drug Details [pdf]

Directions

Directions

■ Apply liberally 15 minutes before sun exposure.
■ 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. 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.

Warnings

Warnings

For external use only.

Do not use ■ on damaged 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Water, Butyloctyl Salicylate, Benzotriazolyl Dodecyl p-Cresol, Propanediol, Ethylhexyl Methoxycrylene, Methyl Methacrylate Crosspolymer, Niacinamide, Polymethylsilsesquioxane, Lauryl Dimethicone, Pentylene Glycol, 1,2-Hexanediol, Hydroxyethyl Urea, Aminomethyl Propanol, C11-13 Isoalkane, Isododecane, Butylene Glycol, Methylpropanediol, Behenyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Tripropylene Glycol, Vinyl Dimethicone, Dipropylene Glycol, Dimethiconol, Poly C10-30 Alkyl Acrylate, Polyacrylic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tromethamine, Polyether-1, Fragrance (Parfum), Ethylhexylglycerin, Sodium Stearoyl Glutamate, Sphingomonas Ferment Extract, Centella Asiatica Leaf Extract, Madecassoside, Sodium Hyaluronate, Biosaccharide Gum-1, Centella Asiatica Extract, Tocopherol, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Madecassic Acid, Asiatic Acid, Asiaticoside

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.

Keep out of reach of children

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

Purpose

Sunscreen

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIHEAL MADECASSOSIDE MOISTURE SUN SERUM 
homosalate, octocrylene, octisalate, ensulizole lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74005-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2.5 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
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MADECASSIC ACID (UNII: M7O1N24J82)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
NIACINAMIDE (UNII: 25X51I8RD4)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
TOCOPHEROL (UNII: R0ZB2556P8)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
TROMETHAMINE (UNII: 023C2WHX2V)
PROPANEDIOL (UNII: 5965N8W85T)
TRIPROPYLENE GLYCOL (UNII: 3C8845E7C1)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ASIATIC ACID (UNII: 9PA5A687X5)
ASIATICOSIDE (UNII: PKO39VY215)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
ISODODECANE (UNII: A8289P68Y2)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74005-002-01	1 in 1 BOX	05/01/2026
1		50 mL in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 74005-002-02	1 in 1 BOX	05/01/2026
2		15 mL in 1 CONTAINER; 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	05/01/2026

Labeler - 74005 (557821713)