Sun And Honey Cream
FDA Label NDC 85432-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amara Ventures for the product Sun And Honey (NDC 85432-001). 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 active ingredient                                       purpose, uses, warnings, directions, inactive ingredients, other information, [email protected], product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                       Purpose

Zinc Oxide 10%                                         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 useon broken or damaged skin. 
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Stop use and ask a doctor ifrash occurs.

Directions

  • apply generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours 
  • use a water resistant sunscreen if swimming or sweating
  • 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.

Inactive Ingredients

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Oil Jojoba Esters, Organic Propolis, Organic Cera Alba (Beeswax), Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Salix Alba (Willow Bark) Extract, Xanthan Gum, Glycerin, Gluconolactone & Sodium Benzoate (Geogard Ultra), Potassium Sorbate.

Other Information

  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken

Product Label

Image Description (Image 1)

Image Description (Image 1)

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