Active Ingredients:
Avobenzone 2.0%
Octisalate 5.0%
Octocrylene 7.0%
Bali Body Spf15 Bronze Shimmering Tanning Gel
FDA Label NDC 70630-0038
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bali Body Pty Ltd for the product Bali Body Spf15 Bronze Shimmering Tanning (NDC 70630-0038). 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 ingredients:, purpose, uses, warnings, do not use, when using this 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 skin ageing caused by the sun.
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.
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 centre right away. Please refer to balibody.com for further sun safety instructions.
Directions
- Apply liberally 15 minutes before sun exposure.
- Re-apply your BB at least every 2 hours
- Wear 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 ageing.
- To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including
- Limit time in the sun, especially from 10am - 2pm.
- Wear long sleeved shirts, pants, hats and sunglasses
- Children under 6 months of age: Ask a doctor.
Other Information
- Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fulfillment 29010 Commerce Drive, Valencia CA 91355
Inactive Ingredients
Petrolatum, Caprylic/Capric Triglyceride, Mineral Oil, C12-15 Alkyl Benzoate, Sorbitan Stearate, Propylene Glycol, Mica, Stearalkonium Hectorite, Iron Oxides, Xanthan Gum, Triethanolamine, Propylene Carbonate, Glycine Soja (Soybean) Oil, Fragrance/Parfum, Bisabolol, Beta-Carotene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract
Product Packaging
1 (Illuminating15)
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