SPF 30- zinc oxide lotion

SPF 30 by

Drug Labeling and Warnings

SPF 30 by is a Otc medication manufactured, distributed, or labeled by Eco Skin Care, Baxter Laboratories Pty. Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient.................Purpose
Zinc Oxide 20%.........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

Purified Water (Aqua),
Isoamyl Laurate, Capric/Caprylic Triglyceride,
Sorbitan Stearate, Sucrose Cocoate, Caprylyl
Glycol, Cetearyl Alcohol, Cetearyl Glucoside,
Hydroxypropyl Starch Phosphate, Polyhydroxystearic
Acid, Xanthan Gum, Cucumis Sativus
(Cucumber) Seed Extract*, Rosa Canina
(Rosehips) Seed Oil*, Camellia Sinensis (Green
Tea) Extract*. *Certified Organic

PRINCIPAL DISPLAY PANEL

eco logical skin care

all natural sunscreen lotion

SPF 30+

Face

Hypoallergenic

1.8 oz (e 50g)

INGREDIENTS AND APPEARANCE

SPF 30   FACE
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76105-525
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 g

Inactive Ingredients
Ingredient Name	Strength
ISOAMYL LAURATE (UNII: M1SLX00M3M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SUCROSE COCOATE (UNII: 3H18P0UK73)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
XANTHAN GUM (UNII: TTV12P4NEE)
CUCUMBER SEED (UNII: BT3S9L53JK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76105-525-02	1 in 1 BOX
1	NDC: 76105-525-01	1.8 g in 1 TUBE

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	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture