Leg Body Makeup

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:54

Label at a glance#

ProductLeg Body Makeup
Active ingredientOCTOCRYLENE, OCTISALATE
Label structure11 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 cause by the sun

Dosage and administration

Directions For sunscreen use: 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: - l...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Octisalate 3.2%

Octocrylene 6.2%

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 cause by the sun

Warnings

WARNINGS SECTION

Warnings

For extenal use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep 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

For sunscreen use:

  • 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. - 2p.m.

-wear long-sleeved shirts, pants, hats and sunglasses

  • children under 6 months of age: Ask a doctor

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredientsWater,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.

QUESTIONS or COMMENTS

OTHER SAFETY INFORMATION

Questions or comments?

1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package(Inner) Primary PackagePrimary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageOuter Package (Secondary)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ShadeShadeShade Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4ee46d8-7228-4160-88ad-868cc5abf72fProduct name520260223
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-116-01Leg Body Makeup1 in 1 CARTONCREAM12
68577-116-01Leg Body Makeup100 mg in 1 TUBECREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-116LEG BODY MAKEUP (OCTISALATE, OCTOCRYLENE) CREAM [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d338ec2-dca0-e032-e063-6394a90a69aa.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-11668577-116-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

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
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d338ec2-dca0-e032-e063-6394a90a69aa2024-12-25WarningsExact identifier
ndc (package): 68577-116-01
ndc (product): 68577-116
ndc11 (package): 68577011601
spl id: 2a251aa3-98f3-2790-e063-6394a90a8a0e
spl set id: 0d338ec2-dca0-e032-e063-6394a90a69aa

Reported adverse events (FAERS/openFDA)#

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