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  5. Label Information: Sunscreen

FDA Label for Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. CLAIMS
    13. ADVERSE REACTION SECTION
    14. PRINCIPAL DISPLAY PANEL

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 15%

Octisalate 5%

Oxybenzone 6%


Purpose



Sunscreen


Use



  • 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: Do not use near heat, flame, or while smoking.


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
  • 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 from excessive heat and direct sun
  • avoid long term storage above 40°C (104°F)

Inactive Ingredients



alcohol denat., acrylates/octylacrylamide copolymer, glycerin, Aloe barbadensis leaf extract, fragrance, Cocos nucifera (coconut) oil, mineral oil


Claims



May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Kids Sunscreen Continuous Spray Broad Spectrum SPF 50.

100% Satisfactin Guaranteed!

(888)309-9030


Adverse Reaction Section



DISTRIBUTED BY DOLGENCORP, LLC

100 ISSION RIDGE

GOODLETTSVILLE, TN 37072

737.000/727AA


Principal Display Panel



DG body

Compare to the active

ingredients in Coppertone

Sunscreen Spray

for kids

Broad Spectrum

SPF 50

* Please review the disclaimer below.