Natural Mineral Formula
FDA Label NDC 65692-0747

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product Natural Mineral Formula (NDC 65692-0747). 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 other, otc - active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Otc - Active Ingredient

Active Ingredients: 

Zinc Oxide (18.75%) Non-nanoparticle

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

Warnings
  • For External Use Only 

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - Stop Use


Stop use and as a doctor if • rash occurs

Otc - When Using

When using this product • Keep out of eyes.  Rinse well with water to remove.

Dosage & Administration

Directions •Apply liberally 15 minutes before sun exposure
• Reapply after 80 minutes of swimming or sweating, •Reapply
• immediately after towel drying. •Reapply at least every 2 hours
• 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 protection measures including:
• limit time in the sun, especially from 10a.m. - 2p.m.
• wear long sleeved shirts, pants, hat, and sunglasses.

Inactive Ingredient

Inactive Ingredients: Helianthus Annus (Sunflower) Seed Oil*, Cera Alba (Beeswax)*, 

Simmondsia Chinensia (Jojoba) Seed Oil*, Cocos Nucifera (Coconut) Oil*,

non-GMO Tocopherol (Vitamin E). 

*Organic Ingredients

Other Safety Information

Other Information:  Protect this product from excessive heart and direct sun.

Product Package Labeling

Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

WATER RESISTANT

(80 MINUTES)

1 fl. oz. / 30 ml

Made in the USA

Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403

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* Please review the disclaimer below.