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

Titanium Dioxide  2.0%

Zinc Oxide  7.5%


Sunscreen

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 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.

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


           
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AVALON ORGANICS COQ10 REPAIR WRINKLE DEFENSE BROAD SPECTRUM SPF15 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1805
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-1805-250 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/15/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture(61995-1805)

Revised: 10/2012
Document Id: 0318396b-f0d2-41a9-ac55-64f3ba4523ec
Set id: d5805b6c-30a4-4df4-9ef0-46e1e2868b4e
Version: 1
Effective Time: 20121031
 
The Hain Celestial Group, Inc.