FDA.reportPublic FDA data

MISTINE UV INVISIBLE FACE SHEER SUNSCREEN GEL SPF 50

Manufacturer
COSMAX USA
Effective date
2026-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:49

Label at a glance#

ProductMISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure9 sections

Indications and 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.

Dosage and administration

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,...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone: 3.0%

Homosalate: 15.0%

Octisalate: 5%

Octocrylene: 10%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SAFETY INFORMATION

Other information

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

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

Questions or comments?

customerservice@mistineus.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleCartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-247-01MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 5030 mL in 1 BOTTLE, PUMPGEL301
68577-247-01MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 501 in 1 CARTONGEL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-24768577-247-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISABOLOL24WE03BX2TIACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
GINGERC5529G5JPQIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
SQUALANEGW89575KF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
TOCOPHEROLR0ZB2556P8IACT
ISODODECANEA8289P68Y2IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SILICAETJ7Z6XBU4IACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
57c53e51-f3e7-d50d-e063-6394a90a4d4f4c2cbf47-cd97-2e29-e063-6394a90a37232026-07-29WarningsExact identifier
spl set id: 4c2cbf47-cd97-2e29-e063-6394a90a3723

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.