Drug Facts

AV4611001 AVALON ORGANICS ESSENTIAL LIFT FIRMING MOISTURIZER SPF15 - zinc oxide lotion
The Hain Celestial Group, 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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Zinc Oxide 8.5%

Sunscreen

Helps prevent sunburns
If uses as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun exposure.

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes.Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

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

Apply liberally after cleansing and toning and 15 minutes before sun exposure.
Skin protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher with other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts,pants and sunglasses.

Aloe Barbadensis Leaf Juice (1), Sea Silt extract, Caprylic/Capric Trigluceride, Coco-Caprylate, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Sorbitan Olivate, Cetearyl Glucoside, Aqua (Water), Aurantium Dulcis (Orange) Peel Oil, Cedrus Atlantica Bark Extract, Citrus Limon ( Lemon) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Coriandrum Sativum (Coriander) Fruit Oil, Geranium Maculatum Oil, Lavandula Angustifolia (Lavender) Oil, Pogostemon Cabin (Patchouli) Oil, Rosmarinus Officinalis (Rosemary ) Leaf Oil, Styrax Benzoin Resin Extract, Avena Sativa (Oat) Kernel Extract (1), Camellia Sinensis Leaf Extract (1), Chondrus Crispus (Carrageenan) Extract (1), Glycine Soya (Soybean) Seed Extract (1), Panax Ginseng Root Extract (1), Secale Cereale (Rye) Seed Extract (1), Dehydrohanthan Gum, Sea Silt, Sodium Magnesium Silicate, Alcohol (1 ), Benzyl Alcohol, Potassium Sorbate, Cinnamyl Alcohol, Citral, Coumarin, Limonene, Linalool.

(1) Certified Organic Ingredient

Questions? Visit www.AvalonOrganics.com

image of front label image of back label image of carton label

AV4611001 AVALON ORGANICS ESSENTIAL LIFT FIRMING MOISTURIZER SPF15
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61995-6110
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	8.5 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
WATER
MEDIUM-CHAIN TRIGLYCERIDES
SHEA BUTTER
CETOSTEARYL ALCOHOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:61995-6110-2	1 BOTTLE, DISPENSING ( BOTTLE) in 1 CARTON	contains a BOTTLE, DISPENSING
1		57 g in 1 BOTTLE, DISPENSING	This package is contained within the CARTON (61995-6110-2)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/18/2011

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Operations
The Hain Celestial Group, Inc.		858894996	manufacture

Establishment
Name	Address	ID/FEI	Operations
Ironwood Clay Company, Inc.		248997694	manufacture

Revised: 04/2012 The Hain Celestial Group, Inc.