Otc - Active Ingredient
Active ingredient
Octinoxate 7.5%................................
Beyond Color
FDA Label NDC 10096-0321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avon Products, Inc for the product Beyond Color (NDC 10096-0321). 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
Warnings
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash 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.
Dosage & Administration
Directions
For sunscreen use:
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
Storage And Handling
Other information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients:Diisostearyl Fumarate, Squalane, Barium Sulfate, Polybutene, Microcrystalline Wax/Cire Microcristalline, Ozokerite, DI-C12-15 Alkyl Fumarate, Bismuth Oxychloride/CI 77163, Mica/CI 77019, Polyethylene, Zea Mays (Corn) Starch, Petrolatum, Tocopheryl Acetate, Caprylyl Glycol, Cholesteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Glycerin, Hydrogenated Castor Oil, Silica, Allantoin, Aloe Barbadensis Leaf Extract, Allyl Methacrylates Crosspolymer, Lecithin, Acrylates Copolymer, Parfum/Fragrance, Beeswax/Cire D'Abeille,
Phenyl Trimethicone, Glycine Soja (Soybean) Oil, Retinol, PEG-80 Sorbitan Laurate, Acrylates/Carbamate Copolymer, Iron Oxides, C12-15 Alkyl Benzoate, Collagen, Hyaluronic Acid, Ethylhexyl Palmitate, Biotin/Folic Acid/Cyanocobalamin/Niacinamide/Pantothenic Acid/Pyridoxine/Riboflavin/Thiamine/Yeast Polypeptides, Tribehenin, Lauroyl Lysine, Retinyl Palmitate, Sorbitan Isostearate, Ascorbyl Palmitate, Beta-Carotene, Palmitoyl Oligopeptide.
Otc - Questions
Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada
Package Label.Principal Display Panel
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