Prebel
FDA Label NDC 13630-0096
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging Inc. for the product Prebel (NDC 13630-0096). 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 nude protect spf 70 sunscreen spray, active ingredients, otc - purpose, inactive ingredient, uses, warnings, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%
Homosalate 12.5%
Octisalate 5%
Octocrylene 2.75%
Oxybenzone 6%
Otc - Purpose
Sunscreen
Inactive Ingredient
Diethylhexyl 2,6-Napthalate, Fragrance, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer
Uses
*Helps prevent sunburn
Warnings
For external use only. When using thi sproduct avoid contact with eyes, if so, rinse with water to remove. Stop use and ask a doctor if irritation or rash occurs. Keep out of reach of children. Flammable, do not use near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 40°C (104°F).
Directions
Apply generously to all areas 15 minutes before sun exposure. Spray into hands to apply to face, do not spray directly. Reapply as needed or after towel drying. Ask a doctor before use on children under 6 months of age. Limit sun exposure, wear protective clothing. This product may stain some fabrics.
* Please review the disclaimer below.