MISTINE UV DEFENSE FACE MOISTURIZER SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 by

Drug Labeling and Warnings

MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 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: 2.6%
Homosalate: 6.5%
Octisalate:4.5%
Octocrylene: 9%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risj 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 inches before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spendin time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a susncreen 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

OTHER INFORMATION

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

Water, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butyloctyl Salicylate, Cetearyl Olivate, 1,2-Hexanediol, Methyl Methacrylate Crosspolymer, Panthenol, Phenyl Trimethicone, Sorbitan Olivate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Vinyl Dimethicone, C15-19 Alkane, Cetearyl Alcohol, Hydroxyacetophenone, Glyceryl Stearate, Polyacrylate Crosspolymer-6, Sodium Stearoyl Glutamate, Butylene Glycol, Carbomer, Tromethamine, Tocopherol, Oryza Sativa (Rice) Bran Extract, Sodium Hyaluronate, Lauryl Glucoside, Disodium EDTA, Centella Asiatica Leaf Extract, Sodium Ascorbyl Phosphate.

QUESTIONS

Questions or comments?

customerservice@mistineus.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87458-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.5 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
CARBOMER (UNII: 0A5MM307FC)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
WATER (UNII: 059QF0KO0R)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
TROMETHAMINE (UNII: 023C2WHX2V)
PROPANEDIOL (UNII: 5965N8W85T)
PANTHENOL (UNII: WV9CM0O67Z)
C15-19 ALKANE (UNII: CI87N1IM01)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87458-004-01	1 in 1 CARTON	02/25/2026
1		40 mL in 1 TUBE, WITH APPLICATOR; 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(87458-004)