Anua Zero-cast Moisturizing Finish Sunscreen Spf 50 Lotion
FDA Label NDC 14268-169

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Englewood Lab, Inc. for the product Anua Zero-cast Moisturizing Finish Sunscreen Spf 50 (NDC 14268-169). 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

Avobenzone 3.0%
Homosalate 7.0%
Octisalate 5.0%
Octocrylene 5.0%

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

  • For sunscreen use:
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months: 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

Other Information

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

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolym er, Cetearyl Alcohol, Niacinamide, So dium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydrox yacetophenone, Phenoxyethanol, To copheryl Acetate, Panthenol, Pentaer ythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexan ediol, Sodium Hyaluronate

Questions?

+1-888-899-9083 Monday–Friday (9 a.m.–5 p.m. EST) www.anua.us

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