Santo Remedios Piel Eterna Radiance Sunscreen Primer Spf-42 Lotion
FDA Label NDC 81352-321

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Santo Remedio Llc for the product Santo Remedios Piel Eterna Radiance Sunscreen Primer Spf-42 (NDC 81352-321). 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 ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxide 6%
Zinc Oxide 8%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swimming or sweating.
  • If used as as directed with other sun protection measures (see directions), decreases the risk of 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 Doctor If

  • Rash occurs.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breastfeeding,

Ask a health professional before use.

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 the risk, regularly use 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:

Bis-Vinyl Dimethicone/ Dimethicone, Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetyl, PEG/PPG-10/1 Dimethicone, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Dimethiconol, Helianthus Annus (Sunflower) Oil, Iron Oxides (Black, Red, White, Yellow), Rubus Idaeus (Rasperry) Extract, Silica, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

Questions?

(855) REMEDIO

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