FDA Label for Sunscreen

View Indications, Usage & Precautions

Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Old East Main Co.. 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


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 liberaly 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 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



water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, benzyl alcohol, disodium EDTA, sodium ascorbyl phosphate, fragrance


Disclaimer



May stain or damage some fabrics or surfaces

OCTINOXATE FREE, OXYBENZONE FREE

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


Adverse Reaction



DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIGDE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030


Principal Display Panel



STUDIO SELECTION  ®

SUN

SUNSCREEN LOTION

Broad Spectrum SPF 50

Compare to Sun Bum ® Sunscreen Lotion Broad Spectrum SPF 50*

SPF 50

Dermatologist-Tested

Hypoallergenic

Water-Resistant (80 minutes)

Banana Scent

6 FL OZ (177 mL)


* Please review the disclaimer below.