Rite Aid Baby Sunscreen
FDA Label NDC 11822-9010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Rite Aid Baby Sunscreen (NDC 11822-9010). 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, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 3.0 %

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 7.0%

Oxybenzone 4.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Warnings

For external use only

When Using This Product

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

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts

Keep Out Of Reach Of Children

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

Directions

  • apply generously and evenly before sun exposure and as needed
  • children under 6 months of age:ask a doctor
  • reapply frequently and after towel drying, swimming or perspiring.

Other Information

  • may stain some materials

Inactive Ingredients

Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel

RITE AIDBabySUNSCREEN LOTIONPhotostableBroad Spectrum ProtectionSPF 50RECOMMENDED SKIN CANCERFOUNDATIONVery Water ResistantPEDIATRICIAN TESTEDUVB/UVA Protection8 FL OZ (237 mL)

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