FDA Label for Avobenzone, Homosalate, Octisalate
View Indications, Usage & Precautions
Avobenzone, Homosalate, Octisalate Product Label
The following document was submitted to the FDA by the labeler of this product Vi-jon, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Purpose
Sunscreen
Uses
- helps prevent sunburn
- if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun
Warnings
For external use only
Do Not Use
- on damaged or broken skin
When Using This Product
- keep out of eyes. Rinse with water to remove
Stop Use And Ask A Doctor If
- rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
- apply liberally 15 minutes before sun exposure
- apply to all skin exposed to the sun
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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
- Protect the product from excessive heat and direct sun
Inactive Ingredients
water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glyceryl stearate, neopentyl glycol diheptanoate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate
Adverse Reactions
May stain or damage some fabrics or surfaces
*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Complete Sunscreen Lotion SPF 30.
Manufactured by: Vi-Jon, LLC
8515 Page Ave., St. Louis, MO 63114
Principal Panel Display
SPF 30
SOLAR PLEX
MOISTURIZING SUNSCREEN LOTION
BROAD SPECTRUM SPF 30
Water resistant (80 minutes)
Lightweight feel
Oxybenzone, Octinoxate and Octocrylene free
Compare to Coppertone® Complete Sunscreen Lotion Broad Spectrum SPF 30*
8 FL OZ (236 mL)
* Please review the disclaimer below.