Otc - Active Ingredient
Active Ingredients
Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%
Solar Milk Spf50 Gel
FDA Label NDC 68577-197
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 Solar Milk Spf50 (NDC 68577-197). 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 - stop use, otc - when using, 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 caused by the sun
Warnings
Warnings
- For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - Stop Use
Stop use and ask a doctor if
- rash or irritation develops and lasts
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
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
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months of age ask a doctor Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and ealy 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.
Inactive Ingredient
Inactive Ingredients
Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Methicone, Tocopheryl Acetate Pongamia Glabra Seed Oil, Oryza Saliva (Rice) Bran Extract, Silica, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Dunaliella Salina (Algae) Extract, Haematococcus Pluvialis Extract, Caprae Lac (Goat Milk), Cocos Nucifera (Coconut) Fruit Extract, Lactobacillus/Rice Ferment, Maltitol, Arginine
Package Label.Principal Display Panel
Bottle (Solarmilkspf50 Pkg)
Front Panel (Solarmilkspf50 Pkg3)
Panel (Solarmilkspf50 Pkg1)
* Please review the disclaimer below.
