Otc - Active Ingredient
Active ingredients
Homosalate 10%
Octisalate 5%
Avobenzone 3%
Octocrylene 2.6%
Invisible Sunscreen Spf 40 Cream
FDA Label NDC 68577-196
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 Invisible Sunscreen Spf 40 (NDC 68577-196). 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, indications & usage, 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
Indications & Usage
Uses
- Helps prevent sunburn
- If used as directed with other Sun Protection Measures (see Directions) decrease the risk of skin cancer and early skin aging damaged by the sun
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not useon damaged or broken skin
Otc - When Using
When you use 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
- Apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- 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-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months of age: Ask a doctor
Other Information
Other information
- Protect this product from excessive heat and direct sun
Inactive Ingredient
Inactive Ingredients:
Isodecane, Ethylhexyl Pamitate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsislsesquioxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Sesamum Indicum(Sesame) Seed Extract, Tocopherol, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Lecithin, Fragrance, Silica, Water, PEG-12 Dimethicone/PPG-20 Crosspolymer, Dimethyl Isosorbide, Sodium Benzoate
Package Label.Principal Display Panel
Secondary (Invisiblesunscreenspf40 Outer)
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