Civant 50 Sunscreen Broad Spectrum Spf 50 Lotion
FDA Label NDC 87478-907

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Civant Llc for the product Civant 50 Sunscreen Broad Spectrum Spf 50 (NDC 87478-907). 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 ingredients, purpose, uses, 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 Ingredients

Octocrylene 7.5%
Zinc Oxide 10%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 product is swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally 15 minutes before sun exposure and as needed
  • Children under 6 months of age: ask a doctor
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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-sleeve shirts, pants, hats, and sunglasses

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C13-14 Isoalkane, Camellia Sinensis Leaf Extract, Capryloyl Glycerin/Sebacic Acid Copolymer, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Hydrogenated Polyisobutene, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lactic Acid, Laureth-7, Methyl Dihydroabietate, Niacinamide, Octyldodecanol, Phenoxyethanol, Polyacrylamide, Polyacrylate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Sodium Hyaluronate, Tocopheryl Acetate, Water (Aqua)

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