Otc - Active Ingredient
Active Ingredients
Octisalate 3.2%
Octocrylene 6.2%
Leg Body Makeup Cream
FDA Label NDC 68577-113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Leg Body Makeup (NDC 68577-113). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
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
Warnings
Warnings
For extenal use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When using this productkeep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor ifrash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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:
- children under 6 months of age: Ask a doctor
- limit time in the sun, especially from 10 a.m. - 2p.m.
-wear long-sleeved shirts, pants, hats and sunglasses
Other Information
Other information
- protect the product in this container from excessive heat and direct sun
Inactive Ingredient
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
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 Package (Dermabln Tube)
Outer Package (Dermabln Outerpkg)
Shade Label
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