Avobenzone, Homosalate, Octisalate Lotion
FDA Label NDC 79481-0933

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Avobenzone, Homosalate, Octisalate (NDC 79481-0933). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Disclaimer

*This product is not manufacturedor distributed by Johnson & Johnson Corporation, distributor of Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 55.

May stain or damage some fabrics or surfaces.

Adverse Reaction

Questions

1-888-593-0593

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

www.meijer.com/satisfaction

how2recycle.info

Principal Display Panel

meijer

sheet touch 

sunscreen lotion

BROAD SPECTRUM SPF 55

UVA/UVB SUNSCREEN

SPF 55

WATER RESISTANT 

WATER RESISTANT (80 MINUTES)

CLEAN, LIGHTWEIGHT FEEL

DERMATOLOGIST TESTED

OXYBENZONE, OCTINOXATE AND OCTOCRYLENE FREE

COMPARE TO NEUTROGENA® ULTRA SHEER® SUNSCREEN BROAD SPECTRUM SPF 55*

3 FL OZ (88 mL)

Image Description (Mm01)

Image Description (Mm01)

* Please review the disclaimer below.