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Product NDC Code | 61995-2404 | ||||
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Drug Name | Al0040400 alba ve mineral sunscreen spf35 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | part352 | ||||
Labeler Name | The Hain Celestial Group, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 6.4% Titanium Dioxide 6.8%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aqua (Water), Caprylic Capric Triglyceride, Glyceryl Oleate Citrate, Glycerin, Coco-Caprylate, Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Camomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Polyhydroxystearic Acid, Tocopheryl Acetate, Sodium Chloride, Stearic Acid, Xanthan Gum, Phenoxyethanol, Potassium Sorbate.
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.Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.AL0040400 Alba VE Mineral Sunscreen SPF35 Zinc Oxide, Titanium Dioxide CALENDULA OFFICINALIS FLOWER HYDROGENATED JOJOBA OIL, RANDOMIZED COCO-CAPRYLATE MATRICARIA RECUTITA GLYCERYL OLEATE XANTHAN GUM POLYHYDROXYSTEARIC ACID (2300 MW) MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE PHENOXYETHANOL POTASSIUM SORBATE ALOE VERA LEAF TITANIUM DIOXIDE TITANIUM DIOXIDE GLYCERIN WATER GREEN TEA LEAF GINKGO SODIUM CHLORIDE STEARIC ACID
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.can label
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 Poison Center right away.
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.SHAKE WELL before use. Apply liberally 15 minutes before sun explosure. Hold 4-6 inches away from body when spraying. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well ventillated areas. Reapply after 80 minutes of swimming or sweating, immideately after towel drying and at least every 2 hours. Cildren under 6 months: ask doctor. Sun Protection Measures: Spending time in the sun increasis your risk of skin cancer and early skin aging. To decrease risk, regulary use a sunscreen with Broad Spectrum SPF 15 or higher and other preventive measures including: limit time in sun, especially from 10 am to 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses.
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.For external use only. Do not puncture or incinerate. Contents under preassure. Do not store at temperature above 120°. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop using and ask a doctor if skin rash occurs.
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