Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream Spf 50 Coconut And Vanilla Scented Cream
FDA Label NDC 84953-564

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Poolbar for the product Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream Spf 50 Coconut And Vanilla Scented (NDC 84953-564). 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 drug facts, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 18%

Purpose

Sunscreen

Use

  • 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

Keep Out Of Reach Of Children.

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

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • Sun protection measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF 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

Other Information

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

Inactive Ingredients

Water, Sorbitan Sesquioleate, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Polysorbate 20, Glyceryl Stearate SE, Polysorbate 80, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate Citrate, Propylene Glycol, Cetyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, 3-O-Ethyl Ascorbic Acid, Dodecane, Glycine Soja (Soybean) Oil, Sodium Stearoyl Glutamate, Xanthan Gum, Beta-Carotene, Magnesium Sulfate, Benzyl Alcohol, Dehydroacetic Acid, Tococpheryl Acetate, C13-16 Isoalkane, Heptyl Undecylenate, Citric Acid, Fragrance

Package Labelling:

Label2 (Label2)

Label2 (Label2)

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