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Project reef mineral sunscreen spf-30 - Medication Information

Product NDC Code 81637-289
Drug Name

Project reef mineral sunscreen spf-30

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Zinc oxide 140 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Project Reef LLC
Packages
Package NDC Code Description
81637-289-00 946.35 ml in 1 bottle (81637-289-00)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Zinc Oxide (Non-Nanoparticle) 14.00% Purpose Sunscreen

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 and as needed. • Children under 6 months of age: ask a doctor. • Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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. Sun Protection Measures.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Algae Extract, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, *Butyrospermum Parkii (Shea) Butter, *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, *Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Dehydroacetic Acid, Ethyl Vanillin, Fucus Vesiculosus (Seaweed) Extract, *Glycerin, Glyceryl Stearate, Helianthus Annuus, *Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Rubus Idaeus (Raspberry) Extract, Stearic Acid, Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol. *Denotes Organic Ingredient

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. • Higher SPF gives more sunburn protection • Retains SPF after 80 minutes of swimming or sweating • 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.
PROJECT REEF Mineral Sunscreen SPF-30 ZINC OXIDE ALOE VERA LEAF WATER BENZYL ALCOHOL SHEA BUTTER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CITRIC ACID MONOHYDRATE ORANGE OIL, COLD PRESSED COCONUT OIL DECYL GLUCOSIDE DEHYDROACETIC ACID ETHYL VANILLIN FUCUS VESICULOSUS GLYCERIN GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP HYDROXYETHYL CELLULOSE, UNSPECIFIED LAVENDER OIL PUNICA GRANATUM ROOT BARK RASPBERRY STEARIC ACID TRIDECYL SALICYLATE XANTHAN GUM CORN ZINC OXIDE ZINC CATION

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.
Package Labeling: 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.
Drug Facts Other Information: • Protect the product in this container 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 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? Call 800 914 0146

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 or irritation develops and lasts.

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

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use

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. Not intended for ingestion. 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 or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

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