MISTINE UV DEFENSE FACE SUNSCREEN SPF50- avobenzone, homosolate, octisalate, octocrylene cream

MISTINE UV DEFENSE FACE SUNSCREEN SPF50 by

Drug Labeling and Warnings

MISTINE UV DEFENSE FACE SUNSCREEN SPF50 by is a Otc medication manufactured, distributed, or labeled by BETTER INVENTION LTD, COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone: 2.7%
Homosalate: 9.5%
Octisalate:4.5%
Octocrylene: 5%

PURPOSE

Purpose

Sunscreen

USES

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

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

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-sleeve shirts, pants, hats, and sunglasses.
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Octyldodecanol, Butylene Glycol Dicaprylate/Dicaprate, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Dibutyl Ethylhexanoyl Glutamide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dextrin Palmitate, Tocopheryl Acetate, Squalane, Ascorbyl Tetraisopalmitate, Butylene Glycol, Oryza Sativa (Rice) Bran Extract, 1,2-Hexanediol.

OTHER INFORMATION

Other information

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISTINE UV DEFENSE FACE SUNSCREEN SPF50 
avobenzone, homosolate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87458-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SQUALANE (UNII: GW89575KF9)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87458-005-01	1 in 1 CARTON	02/25/2026
1		18 mg 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	02/25/2026

Labeler - BETTER INVENTION LTD (141262018)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(87458-005)