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| Product NDC Code | 63354-054 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hawaiian tropic everyday active spf30 |
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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 2.2%, Homosalate 7.0%, Octocrylene 4.2%
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, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Dimethicone, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate.
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 Everyday Active SPF30 AVOBENZONE,HOMOSALATE,OCTOCRYLENE PLUMERIA RUBRA FLOWER GUAVA MANGIFERA INDICA SEED BUTTER DIMETHICONE PASSIFLORA INCARNATA FRUIT COCO GLUCOSIDE PAPAYA MANGO PANTHENOL ALOE VERA LEAF AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE DIISOPROPYL ADIPATE CETOSTEARYL ALCOHOL PHENOXYETHANOL BENZYL ALCOHOL DIHEXADECYL PHOSPHATE CHLORPHENESIN EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE SODIUM HYDROXIDE SODIUM ASCORBYL PHOSPHATE WATER GLYCERIN ALKYL (C12-15) BENZOATE CETETH-10 PHOSPHATE XANTHAN GUM
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 HAWAIIAN TROPIC® SPORT SUNSCREEN LOTION EVERYDAY ACTIVE SWEAT | WATER RESISTANT (80 MINUTES) 30 CRUELTY FREE | VEGAN BROAD SPECTRUM SPF 30 UVA/UVB 8 FL. OZ (236 mL) BONUS 35% MORE HAWAIIAN TROPIC® SPORT SUNSCREEN LOTION EVERYDAY ACTIVE SWEAT | WATER RESISTANT (80 MINUTES) 30 CRUELTY FREE | VEGAN BROAD SPECTRUM SPF 30 UVA/UVB 10.8 FL. OZ. (319 mL) Label 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.Other Information • protect this product from excessive heat and direct sun
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if irritation or rash develops
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.
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
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 do not get into eyes. If contact occurs, rinse thoroughly with water
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 May stain some fabrics. Do not use on damaged or broken skin When using this product do not get into eyes. If contact occurs, rinse thoroughly with water Stop use and ask a doctor if irritation or rash develops Keep out of reach of children If 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