FDA Label for Natural Mineral Formula

View Indications, Usage & Precautions

Natural Mineral Formula Product Label

The following document was submitted to the FDA by the labeler of this product Raining Rose, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)

1.5 fl. oz. / 44 ml

L000000

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

Broad Spectrum SPF 30 Sunscreen

NATURAL MINERAL FORMULA

Made in the USA

1.5 fl. oz. / 44 ml

L000000

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* Please review the disclaimer below.