Label: YES TO CARROTS DAILY FACIAL MOISTURIZER SPF 15- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0323-1 - Packager: Autumn Harp, 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 February 19, 2014
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- WARNINGS AND PRECAUTIONS
- Active Ingredients:
- Purpose:
- Uses:
- 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 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.
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Inactive Ingredients
Water, Ethylhexyl Palmitate, Aloe Barbadensis Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Magnesium Aluminum Silicate, Coco-Glucoside, Phenoxyethanol, Daucus Carota Sativa (Carrot) Root Extract*, Cucurbita Pepo (Pumpkin) Seed Oil*, Butyrospermum Parkii Butter, Cetyl Alcohol, Xanthan Gum, Cyamopsis Tetragonoloba (Guar) Gum*, Maris Limus Extract, Glycine Soja (Soybean) Oil, Tocopherol, Aluminum Hydroxide, Gluconolactone, Glyceryl Isostearate, Hydrated Silica, Polyhydroxystearic Acid, Sodium Benzoate, Triethoxycaprylylsilane, Calcium Gluconate, Citric Acid, Potassium Hydroxide. * Certified Organic Ingredient
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INGREDIENTS AND APPEARANCE
YES TO CARROTS DAILY FACIAL MOISTURIZER SPF 15
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0323 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide 3.2 mg in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.9 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ALMOND OIL (UNII: 66YXD4DKO9) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) COCO GLUCOSIDE (UNII: ICS790225B) OXACYCLOHEPTADEC-8-EN-2-ONE, (8Z)- (UNII: 095I377U8F) PHENETHYL ALCOHOL (UNII: ML9LGA7468) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) XANTHAN GUM (UNII: TTV12P4NEE) PUMPKIN SEED OIL (UNII: 6E5QR5USSP) SHEA BUTTER (UNII: K49155WL9Y) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) HYDRATED SILICA (UNII: Y6O7T4G8P9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) GUAR GUM (UNII: E89I1637KE) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARROT (UNII: L56Z1JK48B) 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:51514-0323-1 50 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/30/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0323)