Bali Body Cacao Tanning Oil Spf 15 Oil
FDA Label NDC 70630-0034
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 Cacao Tanning Oil Spf 15 (NDC 70630-0034). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octocrylene 9%
Octisalate 5%
Avobenzone 3%
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
Shake well before use. Apply liberally 15 minutes before sun exposure. Re-apply your BB every 1-2 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 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 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients
Vitis Vinifera Seed Oil, Cocos Nucifera Oil, Olea Europaea Fruit Oil, Theobroma Oil, Dicaprylyl Carbonate, Vp/hexadecene Copolymer, Silica, Tocopherol, Glycine Soja Oil.
Other Information
- Protect this product from excessive heat and direct sun
- Report serious adverse events to: AMS Fulfilment, 29010 Commerce Drive, Valencia CA 91355
Package Labeling
Cacao15 (Cacao15)
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