Active Ingredients
Avobenzone 3%
Homosalate 12%
Octisalate 5%
Avebonzone, Homosalate, Octisalate Spray
FDA Label NDC 76162-943
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 Avebonzone, Homosalate, Octisalate (NDC 76162-943). 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
Flammable: Keep away from fire or flame.
- after application, wait until product dries before approaching a source of heat or flame, or before smoking
Do Not Use
- on damaged or broken skin
When Using This Product
- keep out of eyes. Rinse with water to remove.
- contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
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
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- apply to all skin exposed to the sun
- hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face.
- do not apply in windy conditions
- use in a well-ventilated area and avoid inhalation
- 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
alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate
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
Visit here for more information: http://topbrnds.com/9xi0cq
QUALITY GUARANTEED
Principal Display Panel
Top Care ® everyday
SPORT
sunscreen spray
SPF 50
BROAD SPECTRUM SPF 50
SUNSCREEN UVA/UVB
Formulated without Phthalates, PABA, Dyes, Octinoxate, Octocrylene or Oxybenzone
sweat resistant
water resistant (80 minutes)
NET WT 5.5 OZ (156 g)
Mm01 (Mm01)
* Please review the disclaimer below.
