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 Meijer, Inc.. 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 12%

Octisalate 5%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risK of skin cancer and early skin aging caused by the sun

Warnings



For external use only


Flammable



  • Flammable: keep away from fire or flame. 
  • After application, wait until product dries before approaching a source of heat or flame, or before smoking

Do Not Use



on damaged or broken skin


When Using This Product



  • keep out of eyes. Rinse with water to remove
  • contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F

Stop Use And Ask A Doctor If



rash occurs


Keep Out Of Reach Of Children.



If swallowed, seek immediate medical attention or call a poison control center.


Directions



■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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 in this container from excessive heat and direct sun


Inactive Ingredients



alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, tocopheryl acetate


Claims



*This product is not manufactured or distributed by Sun Bum LLC, distributor of Sun Bum® Premium Moisturizing Sunscreen Spray Broad Spectrum SPF 50.

May stain or damage some fabrics or surfaces


Adverse Reaction



Questions 1-888-593-0593

DISTRIBUTED BY:

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

www.meijer.com/satisfaction


Principal Display Panel



meijer

sunscreen spray

BROAD SPECTRUM SPF 50

UVA/UVB SUNSCREEN

SPF 50

WATER RESISTANT (80 MINUTES)

FRESH BANANA SCENT

OXYBENZONE, OCTINOXATE AND OCTOCRYLENE FREE

COMPARE TO SUN BUM® PREMIUM MOISTURIZING SUNSCREEN SPRAY*

NET WT 5.5 OZ (156 g)


* Please review the disclaimer below.