Seaweed Oil-control Spf 15
FDA Label NDC 57691-904

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 Seaweed Oil-control Spf 15 (NDC 57691-904). 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, otc - when using, otc - stop use, 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.

Otc - When Using

When using this product

  • keep out of eyes. Rinse with water to remove.

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

  • 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, Dimethicone, Phenoxyethanol, Bertholletia Excelsa Seed Oil, Caprylyl Glycol, Fragrance, Xanthan Gum, Carbomer, Potassium Sorbate, Tetrasodium EDTA, Pentylene Glycol, Propylene Glycol, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fucus Vesiculosus Extract, Linalool, Zinc Gluconate, Benzyl Salicylate, Acacia Senegal Gum, Hydrolyzed Wheat Protein, Propylene Glycol Alginate, BHT, Hydrolyzed Algin, Serine, Sodium Stearate, Zinc Sulfate.

Principal Display Panel - 50 Ml Tube Label

THE
BODY
SHOP

THE BODY SHOP
SEAWEED

OIL-CONTROL LOTION
BROAD SPECTRUM SPF 15 SUNSCREEN

WITH MINERAL-RICH SEAWEED
FROM ROARING WATER BAY, IRELAND

50 ml (1.69 US FL OZ)

COMBINATION / OILY SKIN

Principal Display Panel (50 ml Tube Label)

Principal Display Panel (50 ml Tube Label)

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