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| Product NDC Code | 63354-581 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hawaiian tropic silk hydration sunscreen face broad spectrum spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| 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 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0%
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, Diisopropyl Adipate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butylene Glycol, Cetearyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Phenoxyethanol, Isohexadecane, Caprylyl Glycol, Benzyl Alcohol, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Fragrance, Polysorbate 60, Xanthan Gum, Coco-Glucoside, Disodium EDTA, Aminomethyl Propanol, Mica, Tocopheryl Acetate, Titanium Dioxide, Panthenol, Aloe Barbadensis Leaf Juice, Silk Amino Acids, Sodium Ascorbyl Phosphate, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) 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 ), 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 Silk Hydration Sunscreen Face Broad Spectrum SPF 30 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE POLYSORBATE 60 EDETATE DISODIUM ANHYDROUS DIISOPROPYL ADIPATE AMINOMETHYLPROPANOL BUTYLENE GLYCOL CETETH-10 PHOSPHATE DIHEXADECYL PHOSPHATE PAPAYA FERRIC OXIDE YELLOW XANTHAN GUM OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE CHLORPHENESIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) TITANIUM DIOXIDE PLUMERIA RUBRA FLOWER CAPRYLYL GLYCOL COCO GLUCOSIDE OCTOCRYLENE OCTOCRYLENE PASSIFLORA INCARNATA FRUIT ALKYL (C12-15) BENZOATE ISOHEXADECANE MICA HOMOSALATE HOMOSALATE PANTHENOL GUAVA MANGO ALOE VERA LEAF SODIUM ASCORBYL PHOSPHATE WATER BENZYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE CETOSTEARYL ALCOHOL PHENOXYETHANOL AMINO ACIDS, SILK
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 (R) OIL-FREE SUNSCREEN LOTION WEIGHTLESS HYDRATION FACE 12HR MOISTURIZATION 30 CRUELTY FREE / DERM TESTED BROAD SPECTRUM SPF 30 UVA/UVB 1.7 FL. OZ (50mL) PDP Label Back Labels
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 or direct sun
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
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. May stain some fabrics and surfaces 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 a doctor if rash occurs Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children If 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