Rodial Broad Spectrum Spf 50 Drops Anti-blue Light And Pollution Lotion
FDA Label NDC 52456-022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodial Ltd. for the product Rodial Broad Spectrum Spf 50 Drops Anti-blue Light And Pollution (NDC 52456-022). 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, 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 10%
Octinoxate 7.5%
Oxybenzone 6%
Octisalate 5%
Avobenzone 3%

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

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • children under 6 months of age: ask a doctor
  • 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 value 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-sleeved shirts, pants, hats, and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, PEG -100 Stearate, Octyldodecanol, Jojoba Esters, Glyceryl Stearate SE, Propanediol, Phenoxyethanol, Helianthus Annuus (Sunflower) Seed Wax, Saccharide Isomerate, Methyl Methacrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Bisabolol, Echium Plantagineum Seed Oil, Lecithin, Buddleja Officinalis Flower Extract, 1,2-Hexanediol, Carbomer, Disodium EDTA, Sodium Hyaluronate, Acacia Decurrens Flower Extract, Polyglycerin-3, Parfum (Fragrance), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hydroxide, Biosaccharide Gum-4, Dehydroacetic Acid, Ethylbisiminomethylguaiacol Manganese Chloride, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Sodium Citrate, Limonene, Alpha-isomethyl Ionone, Tocopherol, Citronellol.

Questions Or Comments?

  • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

Carton (Carton)

Carton (Carton)

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