Active Ingredients:
OCTINOXATE (2%)
OXYBENZONE (2%)
Aloe Up Dark Tanning Oil Spf 4
FDA Label NDC 61477-216
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aloe Care International, Llc for the product Aloe Up Dark Tanning Oil Spf 4 (NDC 61477-216). 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 active ingredients:, purpose:, uses, directions:, otc - keep out of reach of children, warnings:, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose:
SUNSCREEN
Uses
HELPS PREVENT SUNBURN.
Directions:
• spray liberally and spread evenly 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 conditions
• use in a well-ventilated 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
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.
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.
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.
Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.
Stop use and ask a doctor if rash occurs.
Flammable: Do not use near heat, flame or while smoking.
Inactive Ingredients
Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Retinyl Palmitate (Vitamin A), SD Alcohol 40-B, Tocopheryl Acetate (Vitamin E)
Other Information
• protect this product from excessive heat and direct sun
• avoid spraying on fabrics - could cause discoloration.
Questions Or Comments?
Call toll free 1-800-950-2563 • www.aloeup.com
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