Otc - Active Ingredient
Active Ingredients
Avobenzone 3 percent
Homosalate 15 percent
Octinoxate 5 percent
Octyl Salicylate 5 percent
Oxybenzone 5 percent
Total Suncare Sunscreen Spf 70
FDA Label NDC 49893-500
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Total Suncare Llc for the product Total Suncare Sunscreen Spf 70 (NDC 49893-500). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, user safety warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides moderate protection against sunburn
- Retains SPF after 40 minutes of activity in the water
Directions
- Apply evenly before sun exposure and as needed.
- Hold can about 6in away from body and spray onto skin.
- Do not spray onto face - spray into palm and smooth over face and neck.
- Children under 6 months of age: ask a doctor.
- Reapply as needed or after towel drying, swimming, or perspiring.
Warnings
Warnings
- For External Use Only
- Flammable: Keep away from fire or flame
- UV exposure from the sun increases the risk of skin cancer, premature skin aging,
and other skin damage. It is important to decrease UV exposure by limiting time in
the sun, wearing protective clothing, and using a sunscreen.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash or irritation develops and lasts
- Contents under pressure. Do not puncture or incinerate. Do not store at temperature
above 120 degrees F.
- Keep out of reach of children.
User Safety Warnings
Other Information
- Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may
reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
- May stain some fabrics
- Avoid long term storage above 104 degrees F
- For your protection, this bottle has an imprinted seal around the neck. Do not use if
tamper evident seal is missing, tampered, broken, or destroyed.
Inactive Ingredient
Acrylates / Octylacrylamide Copolymer, Alcohol Denat, Alkyl Benzoate, Aloe Barbadensis Leaf extract, Fragrance, Mineral oil
Package Label.Principal Display Panel
Total SunCare
SUN
SCREEN
SPF 70
Contininous Spray
Water Resistant
BROAD SPECTRUM
UVA/UVB PROTECTION
clear rub-free free formula
fast and easy coverage
Net Contents 6 fl oz (177 ml)
Expiration Date?Lot Number?
Distributed By:
Total Suncare LLC, 100 S. Washington Ave.
Dunellen, NJ 08812, United States
www.sunscreenus.com
Product of China
Total Suncare Sunscreen Spf 70 (Totalsuncare Sunscreen Spf70 New)
* Please review the disclaimer below.
