Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen
Standard Procedure Spf 50 Sunscreen Face And Body Lotion
FDA Label NDC 70157-027
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 for the product Standard Procedure Spf 50 Sunscreen Face And Body (NDC 70157-027). 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
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
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
- If 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 generously and evenly
- Reapply
- after 80 minutes of swimming
- Immediately after towel drying
- at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 broad spectrum SPF 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. to 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
Inactive Ingredient
Inactive Ingredients
Water, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Citric Acid.
Other Safety Information
Other information
- protect the product in this container from excessive heat and direct sun
Otc - Questions
Questions?
1 213-681-1801 or [email protected]
Package Label.Principal Display Panel
Standard Procedure
SPF 50+ sunscreen
For face and body
Broad Spectrum UVA/UVB
80 Minutes Water Resistant
Added Australian Superfruits with Antioxidants and Vitamins A, B + C
* Please review the disclaimer below.
