Otc - Active Ingredient
Active Ingredient Purpose
Avobenzone Sunscreen
Homosalate
Octisalate
Octocrylene
Daily Body Moisturizer Sunscreen Broad Spectrum Spf 50 Cream
FDA Label NDC 70157-029
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 Daily Body Moisturizer Sunscreen Broad Spectrum Spf 50 (NDC 70157-029). 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, other safety information, 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
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 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m. – 2p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients Water, Beeswax, Cyclomethicone, Isopropyl Palmitate, Cetearyl Alcohol, Ceteareth-20, Carbomer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Triethanolamine, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric Acid
Other Safety Information
Other information
- protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
Daily Body Moisturizer
SPF 50+
Non-Greasy
Sunscreen Broad Spectrum SPF50+
Water Resistant (80 Minutes)
5.0 fl. oz. (148 mL)
Daily Body Spf 50 (A762705 148ml Carton Dailybodyus Fa 1)
* Please review the disclaimer below.
