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  5. Label Information: Avobenzone, Homosalate, Octisalate

FDA Label for Avobenzone, Homosalate, Octisalate

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
    14. PRINCIPAL DISPLAY PANEL

Avobenzone, Homosalate, Octisalate 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%


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, butyloctyl salicylate, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, silica, glyceryl stearate, PEG-100 stearate, dimethicone, potassium cetyl phosphate, benzyl alcohol, beeswax, caprylyl methicone, aluminum starch octenylsuccinate, cetyl dimethicone, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, xanthan gum, chlorphenesin, dimethicone/PEG-10/15 crosspolymer, sodium polyacrylate, fragrance, glycerin, disodium EDTA, ethylhexyl stearate, tocopheryl acetate, BHT, trideceth-6, pentylene glycol, benzyl benzoate


Claims



This product is not manufacturedor distributed by Johnson & Johnson Corporation., distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 70.

May stain or damage some fabrics or surfaces.


Adverse Reactions



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DISTRIBUTED BY

OLD EAST MIN CO.

100 MISSION RIDGE,

GOODLETTSVILLE, TN 37072


Principal Display Panel



STUDIO SELECTION

SUN

SHEER TOUCH

SUNSCREEN

SUNSCREEN LOTION

BROAD SPECTRUM SPF 70

COMPARE TO NEUTROGENA® ULTRA SHEER® SUNSCREEN Broad Spectrum SPF 70*

  • Water-Resistant (80 Minutes)
  • Lightweight, clean skin feel

    • SPF 70

    Dermatologist-Tested 

    UVA/UVB Sunscreen

    3 FL OZ (88 mL)

    image description - mm01

    image description - mm01


* Please review the disclaimer below.