Label: YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0322-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
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 9, 2013
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- Official Label (Printer Friendly)
- WARNINGS AND PRECAUTIONS
- Active Ingredients
- Purpose
- Warnings:
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Directions
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor.
Sun Protection Measure Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses.
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Inactive Ingredients
Water, Ethylhexyl Palmitate, Hydrogenated Methyl Abietate, Glyceryl Stearate Citrate, Glycerin, Magnesium Aluminum Silicate, Aluminum Hydroxide, Cetearyl Alcohol, Phenethyl Alcohol, Alcohol, Sodium Magnesium Silicate, Glyceryl Caprylate, Vaccinium Cyanococcus (Blueberry) Fruit Juice, Xanthan Gum, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Limonene, Fragrance, Onopordum Acanthium Flower/Leaf/Stem Extract, Linalool, Aloe Barbadensis Leaf Juice*, Linalool, Citral, Geraniol, Citronellol. * Certified Organic Ingredient
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INGREDIENTS AND APPEARANCE
YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0322 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.0 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6.2 mg in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENETHYL ALCOHOL (UNII: ML9LGA7468) ALCOHOL (UNII: 3K9958V90M) LAPONITE (UNII: D703131383) LOWBUSH BLUEBERRY (UNII: G90PX41VP0) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LIMONENE, (+)- (UNII: GFD7C86Q1W) TOCOPHEROL (UNII: R0ZB2556P8) LAVENDER OIL (UNII: ZBP1YXW0H8) ONOPORDUM ACANTHIUM FLOWERING TOP (UNII: 475866K8C4) ALOE VERA LEAF (UNII: ZY81Z83H0X) LINALOOL, (+)- (UNII: F4VNO44C09) SOYBEAN OIL (UNII: 241ATL177A) CITRAL (UNII: T7EU0O9VPP) GERANIOL (UNII: L837108USY) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0322-1 41 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/22/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0322)
