Otc - Active Ingredient
Oxybenzone​ 7%
Octocrylene 4%
Octisalate 5%
Avobenzone 3%
Homosalate 13%
Xxl Demi Make Up Spf 50
FDA Label NDC 69435-1906
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharma Ltd. for the product Xxl Demi Make Up Spf 50 (NDC 69435-1906). 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, 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
Provides SPF 50 protection
Indications & Usage
Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.
Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.
Dosage & Administration
Directions for Use: Apply generously to face and body regularly before sun exposure and as needed.
Reapply: after 40 minutes before of or 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.
* Please review the disclaimer below.
