Aloe Soothing Moisture Spf 15
FDA Label NDC 57691-889

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Buth-na-bodhaige, Inc., for the product Aloe Soothing Moisture Spf 15 (NDC 57691-889). 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 other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurpose
Avobenzone (3.0% w/w)Sunscreen
Octinoxate (2.9% w/w)Sunscreen
Octisalate (5.0% w/w)Sunscreen
Octocrylene (2.2% w/w)Sunscreen

Uses

  • helps prevent sunburn.

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.

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

  • Apply liberally 15 minutes before sun exposure.

  • 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 sun especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply this product at least every 2 hours.
    • use a water resistant sunscreen if swimming or sweating.
    • 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, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Sesamum Indicum (Sesame) Seed Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, BHT, Avena Sativa (Oat) Kernel Extract, Citric Acid.

Principal Display Panel - 50 Ml Tube Label

THE
BODY
SHOP

THE BODY SHOP
ALOE

SOOTHING MOISTURE LOTION

BROAD SPECTRUM SPF 15 SUNSCREEN

FRAGRANCE-FREE, COLOURANT-FREE,
PARABEN-FREE, ALCOHOL-FREE
WITH PURE, HAND-FILLETED ALOE FROM CAMPECHE, MEXICO

50 ml (1.69 US FL OZ)

FORMULATED FOR
SENSITIVE SKIN

Principal Display Panel (50 ml Tube Label)

Principal Display Panel (50 ml Tube Label)

* Please review the disclaimer below.