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| Product NDC Code | 63354-927 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hawaiian tropic |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Edgewell Personal Care Brands LLC | ||||||||
| 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 Ingredients Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%
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 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, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.
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.Hawaiian Tropic Avobenzone, Homosalate, Octisalate, Octocrylene PASSIFLORA INCARNATA FLOWER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) POLYMETHYLSILSESQUIOXANE (11 MICRONS) DIMETHICONE GLYCERIN BENZYL ALCOHOL COCO GLUCOSIDE HOMOSALATE HOMOSALATE POLY(METHYL METHACRYLATE; 450000 MW) GUAVA MANGO GREEN TEA LEAF DIHEXADECYL PHOSPHATE PARAFFIN XANTHAN GUM ALOE VERA LEAF VINYLPYRROLIDONE/EICOSENE COPOLYMER OCTOCRYLENE OCTOCRYLENE WATER PROPYLENE GLYCOL CARICA PAPAYA WHOLE PLUMERIA RUBRA FLOWER CETETH-10 PHOSPHATE DIISOPROPYL ADIPATE PHENETHYL BENZOATE PHENOXYETHANOL CAPRYLYL GLYCOL AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE CETOSTEARYL ALCOHOL CHLORPHENESIN SODIUM HYDROXIDE EDETATE DISODIUM EDETIC ACID .ALPHA.-TOCOPHEROL ACETATE SODIUM ASCORBYL PHOSPHATE
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.HAWAIIAN Tropic(R) AntiOxidant+ SUNSCREEN LOTION Helps prevent skin damage & skin aging from the sun 30 SPF 30 BROAD SPECTRUM UVA & UVB PROTECTION light weight moisturizing formula with green tea extract 6 FL. OZ (177 mL) Label
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.May stain some fabrics.
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 Infromation protect this product from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call 1-800-NO UV RAY, Mon-Fri
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
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