Select Brand Baby Sunscreen
FDA Label NDC 15127-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Brand Distributors for the product Select Brand Baby Sunscreen (NDC 15127-004). 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, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3.0%Homosalate 13.0%Octisalate    5.0%Octocrylene 7.0%Oxybenzone 4.0%

Purpose

Sunscreen

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

Otc - Keep Out Of Reach Of Children

Keep out of each of children.If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • shake well
  • 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

Select brandthe lower price name brandBabySUNSCREEN50 SPFVery Water ResistantUVB/UVA ProtectionPEDIATRICIAN TESTED8 FL OZ (237 mL)

Uses

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

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