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| Product NDC Code | 79265-8098 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf 50 super shield sport sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | part352 | ||||
| Labeler Name | Babo Botanicals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 17.363%
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 Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel-drying.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive Ingredients BEESWAX* BISABOLOL BUTYROSPERMUM PARKII (SHEA) BUTTER* CALOPHYLLUM TACAMAHACA SEED OIL* CANNABIS SATIVA SEED OIL* EUPHORBIA CERIFERA (CANDELILLA) WAX JOJOBA ESTERS OCTYLDODECYL OLEATE ORYZA SATIVA (RICE) BRAN OIL* ORYZANOL PERSEA GRATISSIMA (AVOCADO) OIL* SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL* THEOBROMA CACAO (COCOA) SEED BUTTER* TOCOPHEROL *Certified Organic ingredient
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. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.SPF 50 Super Shield Sport Sunscreen Mineral Sunscreen SHEA BUTTER CANNABIS SATIVA SEED OIL HYDROGENATED JOJOBA OIL, RANDOMIZED RICE BRAN OIL AVOCADO OIL JOJOBA OIL ORYZANOL WHITE WAX CANDELILLA WAX OCTYLDODECYL OLEATE TOCOPHEROL LEVOMENOL CALOPHYLLUM TACAMAHACA SEED OIL COCOA BUTTER ZINC OXIDE ZINC OXIDE
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 79265-8098-0 Babo Botanicals Super Shield Sport Stick Broad Spectrum Sunscreen SPF 50 100% Zinc Oxide Active Ingredient 80 Minute Water & Sweat Resistant Ultra Sheer & Hypoallergenic Fragrance Free Outer Package Box
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.Primary Container Labeling 79265-8098-1 17 g Inner Container Label
79265-8098 SPF 50 Super Shield Sport Stick Sunscreen Sunscreen product manufactured pursuant to the Final Monograph. Active ingredient Zinc Oxide.
QUESTIONS/ COMMENTS? Questions and comments? Call 1-877-537-BABO
INFORMATION PANEL INFORMATION PANEL
DRUG FACTS PANEL Drug Facts Panel PART 1 Drug Facts Panel PART 2
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 Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Other Information: Protect this product from excessive heat and direct sun
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 doctor Stop use and ask doctor if rash occurs. •
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 When using this product Keep out of eyes. Rinse with water to remove.
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 doctor if rash occurs. • Keep out of reach of children. If a product is 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