FDA.reportPublic FDA data

MISTINE UV DEFENSE FACE SUNSCREEN SPF50

Manufacturer
BETTER INVENTION LTD | COSMAX, INC.
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:47:45

Label at a glance#

ProductMISTINE UV DEFENSE FACE SUNSCREEN SPF50
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure8 sections

Indications and 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.

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 es...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

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

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on 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 if rash 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

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 SAFETY INFORMATION

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeCartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87458-005-01MISTINE UV DEFENSE FACE SUNSCREEN SPF5018 mg in 1 TUBECREAM182
87458-005-01MISTINE UV DEFENSE FACE SUNSCREEN SPF501 in 1 CARTONCREAM12

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87458-00587458-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTYLDODECANOL461N1O614YIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SQUALANEGW89575KF9IACT
AVOBENZONEG63QQF2NOXACTIB
DIISOSTEARYL MALATEQBS8A3XZGQIACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
OCTOCRYLENE5A68WGF6WMACTIB
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ASCORBYL TETRAISOPALMITATE47143LT58AIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
HOMOSALATEV06SV4M95SACTIB
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT

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
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
ndc (package): 87458-005-01
ndc (product): 87458-005
ndc11 (package): 87458000501
spl id: 4bc4dd93-aa13-6e3f-e063-6394a90a6aca
spl set id: 4b9a8f28-9043-8fb7-e063-6294a90a34d3

Reported adverse events (FAERS/openFDA)#

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