Otc - Active Ingredient
Active ingredient
Octinoxate 1.0%................................
Avobenzone 0.5%................................
Octisalate 0.5%................................
Mark
FDA Label NDC 10096-0298
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 Mark (NDC 10096-0298). 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
.................................Sunscreen
.................................Sunscreen
Indications & Usage
Uses
• helps prevent sunburn
Warnings
Warnings
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
• 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
• 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
Storage And Handling
Other information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredient
Inactive Ingredients:
ETHYLHEXYL ISONONANOATE, HYDROGENATED STYRENE/BUTADIENE COPOLYMER, HYDROGENATED POLYISOBUTENE, SILICA SILYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DICALCIUM PHOSPHATE, PARFUM/FRAGRANCE, STEARALKONIUM HECTORITE, PROPYLENE CARBONATE,
SILICA, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE SPARKLE SHADES MAY ALSO CONTAIN: TIN OXIDE, CALCIUM ALUMINUM BOROSILICATE MAY CONTAIN: MICA/CI 77019, TITANIUM DIOXIDE/CI 7789, IRON OXIDES, RED 7 LAKE/CI 15850, RED 30 LAKE/CI 73360, YELLOW 5 LAKE/CI 19140, BLUE 1 LAKE/CI 42090
Otc - Questions
Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada
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