Patricks Sunscreen
FDA Label NDC 40061-990

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by O.p. Products, Inc. for the product Patricks Sunscreen (NDC 40061-990). 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, directions, purpose, otc - keep out of reach of children, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients.............

Avobenzone 2.0%, Octinoxate 7.25%, Octocrylene 9.75%, Oxybenzone 3.0%

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
  • High protection against sunburn and tanning
  • Retains SPF after 40 minutes of activity in the water or sweating

Warnings

  • For external use only. When using this product
  • Keep out of eyes
  • Rinse with warm water to remove.  Stop use and ask doctor if
  • rash or irritation develops and lasts

Directions

  • Apply liberally 30 minutes before sun exposure
  • Children under 6 months of age consult a doctor
  • Reapply as needed or after towel drying, swimming or sweating

Purpose

Purpose...............Sunscreen

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Inactive Ingredients

Water (Aqua), C12-15 Alkyl Benzoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer (Waterproofing), Aloe Barbadensis (Aloe Vera) Leaf Juice, Isododecane, Phenoxyethanol (Preservative), Fragrance (Parfum), Tetrasodium EDTA, Carbomer, Triethanolamine, Sorbitan Oleate (Plant Derived), Tocopheryl Acetate (Vitamin E Acetate), Retinyl Palmitate (Vitamin A Palmitate), Cereus Grandiflorus (Cactus) Flower Extract, Methylisothiazolinone.

Questions or comments: 1-800-411-8801 . patrickssunscreen.com

Package Label.Principal Display Panel

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Image Of Front Of Package (Front)

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