Aloe Up
FDA Label NDC 13630-0041
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging, Inc. for the product Aloe Up (NDC 13630-0041). 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 principal display panel - 177 ml can label, active ingredients, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octinoxate 2 %, and Oxybenzone 2 %
Uses
- helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120oF
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- spray liberally and spread by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face.
- do not apply in windy condiions
- use in well-ventillated area
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
Inactive Ingredients
Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid, C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil, Retinyl Palmitate, SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate
Other Information
- protect this product from excesive heat and direct sun
- avoid spraying on fabrics - could cause discoloration
* Please review the disclaimer below.