Aloe Up
FDA Label NDC 13630-0041

10 label sections · Submitted to the FDA by Prime Packaging, Inc. · Indications, Dosage, Usage, and Precautions

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 active ingredients, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, 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 120 oF

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

Principal Display Panel - 177 Ml Can Label

Principal Display Panel (177 mL Can Label)

Principal Display Panel (177 mL Can Label)

Aloe Up
DARK

TANNING

OIL

SPF

4

CONTINUOUS SPRAY

SUNSCREEN

MOISTURE

RICH FORMULA

WATER RESISTANT

(80 MINUTES)

VITAMIN A, C & E

6 FL OZ (177 mL)

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