Active Ingredient
Zinc Oxide 18.22%
Doctor Babor Solar Defense Mineral Sunscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 44924-902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Babor Cosmetics America Corp for the product Doctor Babor Solar Defense Mineral Sunscreen Broad Spectrum Spf 30 (NDC 44924-902). 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 ingredient, purpose, uses, warnings, do not use, when using the product, stop use and ask a doctor, 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 aging caused by the sun.
Warnings
For external use only.
Do Not Use
on damaged or broken skin.
When Using The Product
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help, or contact a Poison Control Center right away.
Directions
- Apply generously 15 minutes before sun exposure as needed.
- Reapply 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 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 am to 2 pm
- Wear longsleeved shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor.
Inactive Ingredients
water/aqua/eau, caprylic/capric triglyceride, C13-15 Alkane, pentylene glycol, C15-19 Alkane, propanediol, bis-diglyceryl polyacyladipate-2, gluconolactone, polyhydroxystearic acid, polyacrylate crosspolymer-6, cetearyl alcohol, inositol, isostearic acid, lecithin, polyglyceryl-3 polyricinoleate, coco-glucoside, arachidyl alcohol, polyglycerin-3, polyglyceryl-3 lactate/laurate, sodium benzoate, tocopherol, bisabolol, xanthan gum, behenyl alcohol, sodium citrate, sodium dilauramidoglutamide lysine, sclerotium gum, arachidyl glucoside, citric acid, physalis alkakengi calyx extract, sodium phytate, t-butyl alcohol, calcium gluconate, glucose, beta-carotene.
Other Information
Protect this product from excessive heat and direct sun
Questions Or Comments?
You may report serious adverse evenst from the use of this product by calling toll free 1-800-333-4055
Company Information
Made in the USA
Manufactured for:
BABOR Cosmetics America Corp.
2980 NE 207th St, Ste 402 Aventura,
FL 33180 www.babor.com
Product Packaging
1 (Solardefense)
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