Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10%
Octisalate5%
Octocrylene 8%
Protect And Hydrate Radiance Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 70157-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Baxter Laboratories Pty. Ltd. for the product Protect And Hydrate Radiance Sunscreen Broad Spectrum Spf 50 (NDC 70157-030). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
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.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
apply to all skin exposed to the sun
reapply:
- 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: Ask a doctor.
Inactive Ingredient
Water, Beeswax, Cyclomethicone, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Fragrance, Benzyl Alcohol, Hydroxyacetophenone, Carbomer, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Mica, Iron Oxides, Tocopheryl Acetate, Titanium Dioxide, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric
Package Label.Principal Display Panel
Protect & Hydrate Radiance
Shimmer Finish
Sunscreen Broad Spectrum SPF 50+
Water Resistant (80 Minutes)
5.0 fl. oz. (148 mL)
Protect Hydrate Spf 50 (A762707 148ml Carton Protectus)
* Please review the disclaimer below.
