1. Home
  2. Labeler Index
  3. Avert Skincare Inc
  4. 82603-000
  5. Label Information: Avobenzone, Homosalate, Octisalate, Octocrylene

FDA Label for Avobenzone, Homosalate, Octisalate, Octocrylene

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. DISCLAIMER
    13. ADVERSE REACTIONS
    14. PRINCIPAL DISPLAY PANEL

Avobenzone, Homosalate, Octisalate, Octocrylene Product Label

The following document was submitted to the FDA by the labeler of this product Avert Skincare 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 10%

Octisalate 5%

Octocrylene 10%


Purpose



Sunscreen


Uses



  • helps prevent sunburn
  • if used as directed with other sun protections 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 liberally 15 minutes before sun exposure
  • children under 6 months: ask a doctor
  • Hold container 6 to 8 inches from the skin to apply
  • 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

Other Information



  • Protect the product from excessive heat and direct sun
  • May Stain Fabrics

Inactive Ingredients



Acrylates/octylacrylamide copolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, Tocopherol, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, Retinyl palmitate, stearoxytrimethylsilane


Disclaimer



May stain or damage some fabrics or surfaces

Oxybenzone & Octinoxate free

Reef Safe

Non- Comedogenic


Adverse Reactions



Questions? 1-800-661-5804


Principal Display Panel



Unscented Sunscreen

SPF 50

water resistant 80 minutes

Facemist

BROAD

SPECTRUM

SPF 50

3.38 FL OZ (100 ML)


* Please review the disclaimer below.