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| Product NDC Code | 63354-420 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 2.7%, Homosalate 8.0%, Octisalate 4.5%, Octocrylene 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 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, Isohexadecane, Diisopropyl Adipate, C12-15 Alkyl Benzoate, Butylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Caprylyl Glycol, Fragrance, Methylparaben, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylparaben, Polysorbate 60, Disodium EDTA, Xanthan Gum, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Iron Oxides.
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 ), decrease 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 XANTHAN GUM AMINOMETHYLPROPANOL BROWN IRON OXIDE .ALPHA.-TOCOPHEROL ACETATE PANTHENOL SODIUM ASCORBYL PHOSPHATE COLOCASIA ESCULENTA ROOT PASSIFLORA INCARNATA FRUIT PLUMERIA RUBRA FLOWER DIISOPROPYL ADIPATE ALKYL (C12-15) BENZOATE BUTYLENE GLYCOL EDETATE DISODIUM EDETIC ACID ISOHEXADECANE AMINO ACIDS, SILK AVOBENZONE AVOBENZONE WATER HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL PHENOXYETHANOL CAPRYLYL GLYCOL METHYLPARABEN CETETH-10 PHOSPHATE TITANIUM DIOXIDE ALOE VERA LEAF CARICA PAPAYA WHOLE MANGIFERA INDICA WHOLE PSIDIUM GUAJAVA WHOLE OCTOCRYLENE OCTOCRYLENE MICA DIHEXADECYL PHOSPHATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE
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) Silk HYDRATION(R) Lotion Sunscreen WEIGHTLESS Feels as If It's barely on 50 BROAD SPECTRUM SPF 50 12 HOUR Moisturization* with hydrating ribbons UVA & UVB protection RECOMMENDED SKIN CANCER FOUNDATION Recommended as an effective broad spectrum sunscreen 6 FL. OZ. (177 mL) PDP Label Back Label
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 product is swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information 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? 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