Otc - Active Ingredient
Active Ingredients: Purpose:
Avobenzone 2.0%, Octyl Salicylate 5.0%, Octocrylene 7.0% Sunscreen
Balibody Spf15 Bronze Shimmering Tanning Gel
FDA Label NDC 70157-024
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 Balibody Spf15 Bronze Shimmering Tanning Gel (NDC 70157-024). 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 ageing caused by the sun.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 ou tof eyes. Rinse with water to remove. If product is swallowed, get medical help or contact a poison control center right away. Please refer to balibodyco.com for further sun safety instructions.
Dosage & Administration
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 protective measures including. Limit time in the sun, especially from 10am-2pm. Wear long sleeved shirts, parts, hats and sunglasses. Children under 6 months of age: Ask a doctor.
Inactive Ingredient
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-Carolene, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, BHT, Tocopheryl Acetate, Isochrysis Galbana Extract.
Other Safety Information
Other information: Protect this product from excessive heat and direct sun. Report serious adverse events to: AMS Fullfilment 29010 Commerce Drive, Valencia CA 91355.
Package Label.Principal Display Panel
BaliBody
SPF 15 Bronze Shimmering Tanning Gel
150g 5.07fl.oz
* Please review the disclaimer below.
