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| Product NDC Code | 70793-020 | ||||
|---|---|---|---|---|---|
| Drug Name | Absolutely natural broad spectrum spf 30 sunscreen |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Absolutely Natural, Inc. | ||||
| 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 ingredient Zinc Oxide 18%
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 and evenly 15 minutes prior to sun exposure. • Reapply after 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours. • Children under 6 months of age: Ask a doctor. 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 long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients • Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate, fragrance.
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.Absolutely Natural Broad Spectrum SPF 30 Sunscreen Zinc Oxide ZINC OXIDE ZINC CATION ALOE VERA LEAF ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOSTEARATE SUNFLOWER OIL CASTOR OIL YELLOW WAX RICE BRAN SORBITAN SESQUIOLEATE GLYCERIN CETYL ALCOHOL STEARYL ALCOHOL MAGNESIUM ALUMINUM SILICATE SHEA BUTTER CAMELLIA SINENSIS FLOWER ILEX PARAGUARIENSIS LEAF ROSA CANINA FRUIT OIL .ALPHA.-TOCOPHEROL ACETATE SAFFLOWER OIL RASPBERRY SQUALANE XANTHAN GUM PROPANEDIOL ETHYLHEXYLGLYCERIN POTASSIUM SORBATE
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.Packaging IMAGE IMAGE
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
WATER RESISTANT (40 MINUTES) With Rose Hips Oil REEF SAFE SINCE 1992 Please recycle this container. This product is biodegradable and reef safe. Distributed By: Absolutely Natural, Inc., 640 Atlantis Rd, Melbourne, FL 32904 www.Absolutely-Natural.com
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 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 us! (800) 848-7623
Storage and handling
Information about safe storage and handling of the drug product.Other information • Protect this product from excessive heat and direct sun.
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 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 doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact 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