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 Rite Aid Corporation. 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 risk 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
    • mmediately 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, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal


Adverse Event



*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Lotion Sport Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces.

DISTRIBUTED BY: RITE AID

200 NEWBERRY COMMONS, ETTERS, PA 17319

www.riteaid.com


Principal Display Panel



Comapre to Coppertone® Sunscreen Lotion Sport Broad Spectrum SPF 30*

SPORT

WATER RESISTANT

(80 MINUTES)

SUNSCREEN LOTION

BROAD SPECTRUM SPF 30

UVA/UVB Sunscreen

Won't run when you start to sweat

Helps prevent sunburn

30

8 FL OZ (236 mL)


* Please review the disclaimer below.