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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. USES
    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 REACTIONS 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 10%

Octisalate 4.5%

Octocrylene 8%


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


Claims



This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Spectrum SPF 50

Oxybenzone & Octinoxate Free

May stain or damage some fabrics or surfaces


Adverse Reactions Section



DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

924.000/924AA


Principal Display Panel



STUDIO

SELECTION

SUN

SPORT

SUNSCREEN

LOTION

BROAD SPECTRUM

SPF 50

Compare to Coppertone Sport Broad Spectrum SPF 50

SPF 50

* Please review the disclaimer below.