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Name:All Natural Suncreen
Manufacturer:Eco Skin Care
Category:Over-the-counter (OTC) Marketed Drugs


Eco Logicial Skin Care

ALL NATURAL  SUNCREEN - zinc oxide lotion 
Eco Skin Care

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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Eco Logicial Skin Care

Active Ingredient................Purpose:
Zinc Oxide 22%..........prevention of sunburn

Provides high protection. Helps
protect against sunburn.

Keep out of reach of children.

For external use only

When using this product: Keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if: Rash or
irritation develops and lasts.

Apply smoothly and evenly to
exposed areas 20 minutes before sun exposure.
Repeat as necessary and after towel drying,
swimming or sweating. For adults and children
of all ages. For children under 6 months consult
a doctor.

Capric/Caprylic Triglyceride, Vitis Vinifera (Grape) Seed Oil, Silicon
Dioxide, Cera Alba (Beeswax), Butyrospermum Parkii
Seed (Shea) Butter, Euphorbia Antisyphilitica (Candelilla)
Wax, Polyhydroxystearic Acid, Simmondsia Chinensis
(Jojoba), Cucumis Sativus (Cucumber) Seed
Extract*, Persea Gratissima (Avocado), Rosa Canina
(Rosehips) Seed Oil*, Carota Sativa (Carrot) Oil, Botswellia
Carterii (Frankincense), Camellia Sinensis (Green
Tea) Extract*. *Certified Organic



image of back label

eco logical skin care

all natural sunscreen

SPF 30+ Body

hypoallergenic

5.3 oz (150g)



image of front label


ALL NATURAL   SUNCREEN
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76105-714
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (Zinc Oxide) Zinc Oxide 22.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
GRAPE SEED OIL  
SILICON DIOXIDE  
SHEA BUTTER  
CANDELILLA WAX  
JOJOBA OIL  
CUCUMBER SEED  
AVOCADO  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76105-714-02 1 TUBE ( TUBE) in 1 BOX contains a TUBE (76105-714-01)
1 NDC:76105-714-01 5.3 g in 1 TUBE This package is contained within the BOX (76105-714-02)
2 NDC:76105-714-04 1 TUBE ( TUBE) in 1 BOX contains a TUBE (76105-714-03)
2 NDC:76105-714-03 3.5 g in 1 TUBE This package is contained within the BOX (76105-714-04)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 03/22/2011

Labeler - Eco Skin Care (966826914)
Registrant - Eco Skin Care (966826914)
Establishment
Name Address ID/FEI Operations
Baxter Laboratories Pty. Ltd. 740537709 manufacture

Revised: 03/2011 Eco Skin Care



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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