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Hawaiian tropic mineral skin nourishing milk coconut oil spf 50 - Medication Information

Product NDC Code 63354-703
Drug Name

Hawaiian tropic mineral skin nourishing milk coconut oil spf 50

Type Brand
Active Ingredients
Titanium dioxide 4.9 g/100g
Zinc oxide 6.7 g/100g
Route TOPICAL
Dosage Form OIL
Application Number M020
Labeler Name Edgewell Personal Care Brands LLC
Packages
Package NDC Code Description
63354-703-12 100 g in 1 bottle (63354-703-12)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Titanium Dioxide 4.9%, Zinc Oxide 6.7% .

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, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone, Stearyl/Octyldodecyl Citrate Crosspolymer, Polyhydroxystearic Acid, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, 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 Mineral Skin Nourishing Milk Coconut Oil SPF 50 Titanium Dioxide, Zinc Oxide ZINC OXIDE ZINC OXIDE ALKYL (C12-15) BENZOATE DIMETHICONE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) ALUMINUM OXIDE PROPYLENE CARBONATE MICA GUAVA PLUMERIA RUBRA FLOWER PAPAYA KUKUI NUT OIL ETHYLHEXYLGLYCERIN PASSIFLORA INCARNATA FRUIT CAPRYLYL GLYCOL WATER COCONUT OIL FERRIC OXIDE YELLOW GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES TITANIUM DIOXIDE TITANIUM DIOXIDE MANGO TRIETHOXYCAPRYLYLSILANE DEHYDRATED ALCOHOL SODIUM CHLORIDE PHENOXYETHANOL POLYHYDROXYSTEARIC ACID (2300 MW) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER

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 SUNSCREEN LOTION MINERAL SKIN NOURISHING MILK 50 CRUELTY FREE | VEGAN BROAD SPECTRUM SPF 50 UVA/UVB 3.4 FL. OZ (100mL) 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 rash occurs.

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

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

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