SOLMED SUNSCREEN FACE SHIELD- avobenzone, ethylhexyl salicylate, homosalate, octocrylene cream

SOLMED SUNSCREEN FACE SHIELD by

Drug Labeling and Warnings

SOLMED SUNSCREEN FACE SHIELD by is a Otc medication manufactured, distributed, or labeled by FEELFREE LLC, KONAD CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Ethylhexyl Salicylate 5%

Homosalate 10%
Octocrylene 10%

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.

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, Butyloctyl Salicylate, Polyglyceryl-6 Stearate, Ethylhexyl Methoxycrylene, Niacinamide,

Poly C10-30 Alkyl Acrylate, Sorbitan Sesquioleate, Silica, Behenyl Alcohol, 1,2-Hexanediol, Hydroxyacetophenone,

Sodium Polyacryloyldimethyl Taurate, Polyglyceryl-6 Behenate, Polyacrylate Crosspolymer-6, Sphingomonas Ferment Extract, Tocopheryl Acetate, Panthenol, Disodium EDTA, Adenosine, Centella Asiatica Extract, Monarda Didyma Leaf Extract,

Mentha Piperita Leaf Extract, Lavandula Angustifolia Flower Extract, Freesia Refracta Extract, Rosmarinus Officinalis Leaf Extract, Chamomilla Recutita Flower Extract, Asiaticoside, Caprylyl Glycol, Madecassoside, Madecassic Acid, Asiatic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLMED SUNSCREEN FACE SHIELD 
avobenzone, ethylhexyl salicylate, homosalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85446-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 50 g
ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	ETHYLHEXYL SALICYLATE	2.5 g  in 50 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
PANTHENOL (UNII: WV9CM0O67Z)
ASIATIC ACID (UNII: 9PA5A687X5)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ADENOSINE (UNII: K72T3FS567)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICA (UNII: ETJ7Z6XBU4)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MADECASSIC ACID (UNII: M7O1N24J82)
NIACINAMIDE (UNII: 25X51I8RD4)
ROSEMARY (UNII: IJ67X351P9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
MONARDA DIDYMA LEAF (UNII: JY15982UBB)
ASIATICOSIDE (UNII: PKO39VY215)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85446-045-02	1 in 1 BOX	03/31/2025
1	NDC: 85446-045-01	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	03/31/2025

Labeler - FEELFREE LLC (136710889)

Establishment
Name	Address	ID/FEI	Business Operations
KONAD CO LTD		688329887	manufacture(85446-045)