ORGANIC SUNSCREEN- zinc oxide cream

Organic Sunscreen by

Drug Labeling and Warnings

Organic Sunscreen by is a Otc medication manufactured, distributed, or labeled by NATURE'S NATURAL PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Actives 

Non-Nano Zinc Oxide 20 % 

Inactives

Spring water, Grapeseed oil, Aloe vera, Vegtable wax,Beeswax, Vitamin E, Lecithin, aspen tree bark, fermented horseradish root

Purpose

Helps prevent sunburn if used as directed

Directions

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  

 - Limit time in the sun, especially from 10am-2pm    

-  For children under 6 months of age: ask a doctor

 - Wear long-sleeved shirts, pants, hats, and sunglasses                                                  

Warnings

For external use only.
Do not use on skin that is broken or infl­amed if you are allergic to ingredients in this product
When using this product avoid contact with eyes if product gets into eyes, rinse thoroughly with water
Stop use and ask a doctor if rash appears, condition worsens or does not improve in 2-4 weeks
If pregnant or breast-feeding, ask a doctor before use.

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Product Label 

INGREDIENTS AND APPEARANCE

ORGANIC SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71371-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POPULUS ALBA BARK (UNII: K12723D3GV)
YELLOW WAX (UNII: 2ZA36H0S2V)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
HORSERADISH (UNII: 8DS6G120HJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71371-001-20	236 mL in 1 PACKAGE; Type 0: Not a Combination Product	04/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/05/2017

Labeler - NATURE'S NATURAL PRODUCTS, INC (080235960)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE'S NATURAL PRODUCTS, INC		080235960	manufacture(71371-001)