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| Product NDC Code | 63354-421 | ||||
|---|---|---|---|---|---|
| Drug Name | Hawaiian tropic mineral skin nourishing milk sunscreen broad spectrum spf 30 |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 15.0%
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 • shake well • 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 longsleeved 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, Isododecane, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Cocos Nucifera (Coconut) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Fragrance, Triethoxycaprylylsilane, Aleurites Moluccanus Seed Oil, Tocopheryl Acetate, Sodium Citrate, Aloe Barbadensis Leaf Juice, Glycerin, Mica, Titanium Dioxide, Carica Papaya (Papaya) Fruit 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 ), 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 Mineral Skin Nourishing Milk Sunscreen Broad Spectrum SPF 30 ZINC OXIDE ZINC OXIDE ZINC OXIDE WATER ISODODECANE COCONUT OIL ALOE VERA LEAF TITANIUM DIOXIDE PAPAYA PLUMERIA RUBRA FLOWER BUTYLOCTYL SALICYLATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER ANHYDROUS TRISODIUM CITRATE MANGO GLYCERIN MICA PASSIFLORA INCARNATA FRUIT GUAVA KUKUI NUT OIL FERRIC OXIDE YELLOW POLYHYDROXYSTEARIC ACID (2300 MW) .ALPHA.-TOCOPHEROL ACETATE
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 NEW HAWAIIAN TROPIC(R) MINERAL SKIN NOURISHING MILK 30 SUNSCREEN BROAD SPECTRUM SPF30 UVA/UVB OXYBENZONE & OCTINOXATE FREE CRUELTY-FREE SHAKE WELL BEFORE USE 3.4 FL. OZ. (100 mL) 63354-421-12 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
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.
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. Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. May stain some fabrics. 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.
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