NATURAL MINERAL FORMULA- zinc oxide lotion

Natural Mineral Formula by

Drug Labeling and Warnings

Natural Mineral Formula by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredients: 

Zinc Oxide (18.75%) Non-nanoparticle

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS

Warnings

• For External Use Only 

DO NOT USE

• Do not use on damaged or broken skin

STOP USE

Stop use and as a doctor if rash occurs

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

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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INGREDIENTS AND APPEARANCE

NATURAL MINERAL FORMULA 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0738
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8.25 g  in 44 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0738-1	44 mL in 1 TUBE; Type 0: Not a Combination Product	08/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/16/2019

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)