MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene gel

MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 by

Drug Labeling and Warnings

MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone: 3.0%

Homosalate: 15.0%

Octisalate: 5%

Octocrylene: 10%

PURPOSE

Purpose

Sunscreen

USES

Uses

• help 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 useon damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash 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

Isododecane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Tocopherol, Squalane, Silica, Bisabolol, Ascorbyl Tetraisopalmitate, Zingiber Officinale (Ginger) Root Extract, Butylene Glycol, Oryza Sativa (Rice) Bran Extract, 1,2-Hexanediol.

OTHER INFORMATION

Other information

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

QUESTIONS OR COMMENTS

Questions or comments?

customerservice@mistineus.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BISABOLOL (UNII: 24WE03BX2T)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GINGER (UNII: C5529G5JPQ)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
SQUALANE (UNII: GW89575KF9)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SILICA (UNII: ETJ7Z6XBU4)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-247-01	1 in 1 CARTON	02/25/2026
1		30 mL in 1 BOTTLE, PUMP; 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 - COSMAX USA (010990210)

Registrant - COSMAX USA (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA		010990210	manufacture(68577-247)