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| Product NDC Code | 55560-0104 | ||||
|---|---|---|---|---|---|
| Drug Name | Perfecting bb beauty balm natural tint spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Andalou naturals | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Daily, alone or under make-up. Apply liberally 15 minutes before sun exposure and as needed. Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking. Use water resistant sunscreen if swimming or sweating. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses. Children under 6 months: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non Medicinal Ingredients Aloe Barbadensis Leaf Juice Certified Organic/Organic , Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil , Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil , Punica Granatum (Pomegranate) Seed Oil , Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex , Sodium Hyaluronate, Resveratrol, Ubiquinone (CoQ10), Borago Officinalis (Borage) Seed Oil , Cucumis Sativus (Cucumber) Fruit Extract , Zea Mays (Corn) Starch , Camellia Sinensis (White Tea) Leaf Extract Fair Trade/Biologique , Hibiscus Sabdariffa Flower Extract , Tocopherol, Iron Oxides, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent sunburn.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Perfecting BB Beauty Balm Natural Tint SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN JOJOBA OIL POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-2 STEARATE SUNFLOWER OIL POMEGRANATE SEED OIL HYDROGENATED CASTOR OIL DIMETHICONE MAGNESIUM SULFATE, UNSPECIFIED FORM SORBITAN SESQUIOLEATE APPLE VITIS VINIFERA SEED ACAI ARONIA MELANOCARPA FRUIT JUICE ARCTOSTAPHYLOS UVA-URSI LEAF VACCINIUM MYRTILLUS ANTHOCYANOSIDES EUROPEAN ELDERBERRY JUICE LYCIUM BARBARUM FRUIT ROSA CANINA FRUIT HIPPOPHAE RHAMNOIDES FRUIT HYALURONATE SODIUM RESVERATROL UBIDECARENONE BORAGE SEED OIL CUCUMBER STARCH, CORN WHITE TEA HIBISCUS SABDARIFFA FLOWER TOCOPHEROL FERRIC OXIDE YELLOW PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MANDARIN OIL ORANGE OIL, COLD PRESSED
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton NEW LOOK ANDALOU NATURALS NON GMO BB Perfecting BEAUTY BALM Natural Tint SPF 30 with Resveratrol Q10 Youthful Vitality Broad Spectrum Protection FRUIT STEM CELL SCIENCE ® AGE DEFYING NPN 80051229 2 fl oz e 58 mL Principal Display Panel - 58 mL Tube Carton
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Dist. by Andalou Naturals Novato, CA 94945 USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions Call (888) 898-6955 or visit www.Andalou.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash or irritation develops and lasts.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product in this container from excessive heat and direct sun.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API