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| Product NDC Code | 79950-004 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Bondi sands fragrance free spf 30 sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | BONDI SANDS (USA) INC. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 8%
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 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Aqua/Eau, Beeswax/Cera Alba/Cire d'abeille, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Saccharide Isomerate, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Sodium Chloride, Citric Acid.
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 protections measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun. Retains SPF after 80 minutes of activity in the water.
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.Bondi Sands Fragrance Free SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene PHENOXYETHANOL SODIUM STEAROYL GLUTAMATE AVOBENZONE AVOBENZONE SACCHARIDE ISOMERATE BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE WATER ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL PALMITATE CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 CYCLOMETHICONE 6 POLYOXYL 20 CETOSTEARYL ETHER HYDROXYACETOPHENONE YELLOW WAX OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE CITRIC ACID MONOHYDRATE SODIUM CHLORIDE OCTISALATE OCTISALATE TROLAMINE
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.Product Packaging bondi sands The Australian tan BROAD SPECTRUM SPF 30 VERY WATER RESISTANT 80 MINUTES FRAGRANCE FREE SUNSCREEN LOTION REEF FRIENDLY 72HY HYDRATION SUITABLE FOR SENSITIVE SKIN Australian Made 5.07 FL. OZ. (150mL) lotion spf30
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
Company Information Made in Australia. Distributed by Bondi Sands USA Wilmingon, 19808, DE. bondisands.com
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sun. You may report a serious adverse reaction to 888-266-0772; Monday – Friday, 9 am – 5 pm.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 888-266-0772 or visit bondisands.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 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 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if 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