GREEN SUNBLOCK- zinc oxide cream 
Iruri Nature Handmade Soap & Cosmetic 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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Green Sunblock (Camellia oil & Pumpkin seed oil)

Active Ingredients

Zinc oxide (8%)

Purpose

Sunscreen

Warings

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Keep out of reach of children

. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.

2. Apply liberally 15 minutes before sun exposure.

3. Reapply at least every 2 hours.

4. Use a water-resistant sunscreen if swimming or sweating.

5. 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 sun protection measures including:

1) Limit time in the sun, especially from 10 a.m.

- 2 p.m.

2) Wear long-sleeved shirts, pants, hats, and

sunglasses.

Children under 6 months of age: ask a doctor

Uses

Helps prevent sunburn

Inactive Ingredients

Castor oil, Grape seed oil, Pumpkin seed oil, Allantoin, Emulsifying wax, Distilled water, Lavender water, Glycerin, Vitamin E oil, Optiphen plus, Aspen Grass Fragrance oil

Green Sunblock (Camellia oil & Pumpkin seed oil)

Green Sunblock (Camellia oil & Pumpkin seed oil)

GREEN SUNBLOCK 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71547-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.6 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
GLYCERIN (UNII: PDC6A3C0OX)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALLANTOIN (UNII: 344S277G0Z)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71547-104-021 in 1 PACKAGE07/24/2017
1NDC:71547-104-0120 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/20/2017
Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041)
Establishment
NameAddressID/FEIBusiness Operations
Iruri Nature Handmade Soap & Cosmetic Inc095675041manufacture(71547-104)

Revised: 7/2017
Document Id: 54c69554-0b0b-27e7-e054-00144ff8d46c
Set id: 54c69554-0b0a-27e7-e054-00144ff8d46c
Version: 2
Effective Time: 20170724
 
Iruri Nature Handmade Soap & Cosmetic Inc