AVALON ORGANICS COQ10 REPAIR WRINKLE DEFENSE BROAD SPECTRUM SPF15- zinc oxide, titanium dioxide cream

Avalon Organics COQ10 Repair Wrinkle Defense Broad Spectrum SPF15 by

Drug Labeling and Warnings

Avalon Organics COQ10 Repair Wrinkle Defense Broad Spectrum SPF15 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide  2.0%

Zinc Oxide  7.5%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

WARNINGS

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

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

DOSAGE & ADMINISTRATION

Apply liberally after cleansing and toning at 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 risk, regularly use a sunscreen  with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in the sun, especially from 10am to 2pm and wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice (1), Aqua (Water), Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Glyceryl Stearate, Cetyl Alcohol, Glycerin, Polyglycerol-10 Laurate, Cetearyl Olivate, Magnesium Aluminum Silicate, Sorbitan Olivate, Arnica Montana Flower  Extract (1),Camellia Sinenensis Leaf Extract (1), Chamomilla Recutita (Matricaria ) Flower Extract (1), Lavandula Angustifolia (Lavender) Flower Extract (1), Leucojum Aestivum Bulb Extracr, Butyrospermum Parkii (Shea) Butter (1),Borage Officinalis Seed Oil (1), Cinnamomum Camphora (Camphor) Bark Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Leaf Oil,Lavandula Angustifolia (Lavender) Oil,Prunus Amygdalus Dulcis (Sweet Almond) Oil (1), Rosa Canina Fruit Oil (1), Ribose, Tocopheryl Acetate, Ubiquinone, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool.

(1) Certified Organic Ingredients

QUESTIONS

Questions? Visit AvalonOrganics.com or call (888) 659-7730.

PRINCIPAL DISPLAY PANEL

           

     

         

      

INGREDIENTS AND APPEARANCE

AVALON ORGANICS COQ10 REPAIR WRINKLE DEFENSE BROAD SPECTRUM SPF15 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETYL ALCOHOL (UNII: 936JST6JCN)
JOJOBA OIL (UNII: 724GKU717M)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SORBITAN OLIVATE (UNII: MDL271E3GR)
BORAGE OIL (UNII: F8XAG1755S)
BERGAMOT OIL (UNII: 39W1PKE3JI)
ORANGE OIL (UNII: AKN3KSD11B)
SHEA BUTTER (UNII: K49155WL9Y)
MANDARIN OIL (UNII: NJO720F72R)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
CAMPHOR OIL (UNII: 75IZZ8Y727)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
ALMOND OIL (UNII: 66YXD4DKO9)
RIBOSE, D- (UNII: 681HV46001)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEUCOJUM AESTIVUM BULB (UNII: 190M641M70)
UBIDECARENONE (UNII: EJ27X76M46)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRAL (UNII: T7EU0O9VPP)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-1805-2	50 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/15/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture(61995-1805)