Hydrating Aloe Rich Suncare Spf 15 Broad Spectrum Very Water Resistant 80 Minutes Uva Uvb Protection Cream
FDA Label NDC 53675-209

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aruba Aloe Balm Nv for the product Hydrating Aloe Rich Suncare Spf 15 Broad Spectrum Very Water Resistant 80 Minutes Uva Uvb Protection (NDC 53675-209). 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, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., 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 7.34%
Octocrylene 5%
Octyl Salicylate 5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn.
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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

Stop Use And Ask A Doctor

if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply generously 15 minutes before sun exposure.
  • reapply
    • after 80 minutes of swimming or sweating.
    • immediately after towel drying.
    • at least every 2 hours.
    • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.
    • children under 6 months of age: Ask a doctor.

Other Information

  • protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

* Please review the disclaimer below.