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Product NDC Code | 70983-024 | ||||||||
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Drug Name | Sun guard |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | M020 | ||||||||
Labeler Name | Saje Natural Business Inc | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Zinc Oxide 20%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.SPF 30 Broad-Spectrum Sunscreen Lotion 3.4 fl. oz. | 100ml 6.1 fl. oz. | 180 ml
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 before sun exposure • Children under 6 months of age: ask a doctor • Reapply as needed or after towel drying, swimming or sweating. • Reapply at least every 2 hours • Use water resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Anthemis nobilis flower oil, beeswax (white), calendula officinalis flower, chamomilla recutita (matricaria) flower extract, daucus carota sativa (carrot) seed oil, hippophae rhamnoides fruit extract, olive oil, pelargonium graveolens oil, rosmarinus officinalis (rosemary) leaf extract , santalum album (sandalwood) oil, soybean oil, sunflower oil, vitamin e.
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.Helps protect against sunburn.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sun Guard Zinc Oxide HIPPOPHAE RHAMNOIDES FRUIT OLIVE OIL PELARGONIUM GRAVEOLENS FLOWERING TOP ROSEMARY SOYBEAN OIL SUNFLOWER OIL CHAMAEMELUM NOBILE FLOWER OIL WHITE WAX CALENDULA OFFICINALIS FLOWER CARROT SEED OIL SANDALWOOD OIL ALPHA-TOCOPHEROL CHAMOMILE ZINC OXIDE ZINC OXIDE
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.SUN GUARD - Outer label SUN GUARD_100ml_SUNSCREEN TUBE_USA_FINAL_R1 SUN GUARD_180ml_Sunscreen Tube_USA_FINAL_R1 Sun Guard 50ml
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 • if you are pregnant or breastfeeding • if you are allergic to plants in the Asteraceae/Compositae/Daisy family
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.• Protect the product in this container from excessive heat and direct sun. • Sun alert : Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun. Questions? 1-877-275-7253 distributed by : saje natural wellness 22 east 5th ave vancouver, bc canada v5t 1g8 saje.com 1-877-ask-saje @sajewellness made by our friends in canada
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.For external use only. Do not use if foil seal is broken or missing
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