Active Ingredients
Avobenzone 3%
Homosalate 12%
Octisalate 5%
Avobenzone, Homosalate, Octisalate Lotion
FDA Label NDC 76162-947
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Avobenzone, Homosalate, Octisalate (NDC 76162-947). 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
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 Center right away.
Directions
- apply liberally 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 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
- 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, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol
Disclaimer
May stain or damage some fabrics or surfaces
Adverse Reaction
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO VIJA0326
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
QUALITY GUARANTEED
This TopCare ® product is laboratory tested to guarantee its highest quality. Your total satisfaction is guaranteed.
Scan here for more information or call 1-888-423-0139
Principal Display Panel
TopCare ®
everyday
baby sunscreen lotion
SPF 50
BROAD SPECTRUM SPF 50
SUNSCREEN UVA/UVB
HYPOALLERGENIC*
*Individual skin sensitivities may vary.
WITH ALOE & VITAMIN E
Formulated without Phthalates, PABA, Dyes, Octinoxate, Octocrylene or Oxybenzone
water resistant (80 minutes)
8 FL OZ (236 mL)
Mm01 (Mm01)
* Please review the disclaimer below.
