Otc - Active Ingredient
Octinoxate 4%
Avobenzone 4%
Oxybenzone 3%
Octocrylene 2.7%
Bali Body Bb Cream Spf 15
FDA Label NDC 70630-1605
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 Bb Cream Spf 15 (NDC 70630-1605). 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 package label.principal display panel, otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - Purpose
A multi-tasking beauty cream.
Provides SPF 15 protection.
Indications & Usage
Shake well before use. Apply liberaly 15 minutes before sun exposure.
Children under 6 months old: Ask a doctor.
Re-apply every 2 hours.
Use water-resistant sunscreen if swimming or sweating.
Store in cool dry place.
Warnings
Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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.
Always wear a hat, protective clothing and sunglasses.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
* Please review the disclaimer below.
