Sunscreen
FDA Label NDC 72376-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skin Kidz Cc for the product Sunscreen (NDC 72376-001). 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 purpose, active ingredients, directions, warning and pracaution, ask doctor section, keep out of reach of children section, inactive ingredient, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Sunscreen

Uses

● helps prevent sunburn

● if used as directed with other sun protection measures

  • decreases the risk of skin cancer and early skin aging caused by the sun 

Active Ingredients

Avobenzone 3%, Homosalate 11.7%,
Octisalate 4.5%, Oxybenzone 5.4%,
Octocrylene 4.5%

Directions

● apply generously 15 minutes before sun exposure

● ensure complete coverage to the are above the lip, nose, and tops of ears

● reapply: - after 80 minutes of swimming or sweating – immediately after towel drying – at least every 2 hours.

Warning And Pracaution

●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.

●If rash occurs, stop use and ask a doctor 

Ask Doctor Section

●If rash occurs, stop use and ask a doctor

Keep Out Of Reach Of Children Section

  • KEEP OUT OF REACH OF CHILDREN SECTION
  • If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

ingredients: water, propylene glycol,
polyurethane-34, cetyl alcohol, potassium cetyl
phosphate, glycerin, sorbitan mono stearate,
polysorbate 60, phenoxyethanol,
ethylhexylglycerin, potassium hydroxide,
dimethicone, tocopheryl acetate, acrylates/C10-
30 alkyl acrylate crosspolymer, arginine, sodium
ascorbyl phosphate, disodium EDTA

Product Label

Front Image (Front Label)

Front Image (Front Label)

Drug Facts (Back Panel)

Drug Facts (Back Panel)

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