Label: AVALON ORGANICS COQ10 REPAIR WRINKLE DEFENSE BROAD SPECTRUM SPF15- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-1805-2 - Packager: The Hain Celestial Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 31, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
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INGREDIENTS AND APPEARANCE
AVALON ORGANICS COQ10 REPAIR WRINKLE DEFENSE BROAD SPECTRUM SPF15
zinc oxide, titanium dioxide creamProduct 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)
