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.