NATURAL MINERAL FORMULA- zinc oxide lotion 
Raining Rose, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Broad Spectrum SPF 30 NATURAL MINERAL FORMULA

DRUG FACTS

Active Ingredients: 

Zinc Oxide (18.75%) Non-nanoparticle

Purpose

Sunscreen

Uses

Warnings


Stop use and as a doctor if • rash occurs

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

Keep out of reach of children.

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

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 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 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

SPF30 44mL Front

SPF30 44mL Back

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NATURAL MINERAL FORMULA 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0738
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.25 g  in 44 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
JOJOBA OIL (UNII: 724GKU717M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-0738-144 mL in 1 TUBE; Type 0: Not a Combination Product08/16/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/16/2019
Labeler - Raining Rose, Inc. (083819404)
Registrant - Raining Rose, Inc. (083819404)

Revised: 8/2019
Document Id: dc16ccba-5997-46a9-a80f-c4a70c564d0d
Set id: c5de0eef-532c-4c29-9d92-07af28fddb69
Version: 1
Effective Time: 20190821
 
Raining Rose, Inc.