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| Product NDC Code | 52915-067 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf30 calendula sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | ORGANIC & SUSTAINABLE BEAUTY | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Titanium Dioxide 12%
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 Reapply – after 80 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 Water, calendula officinalis extract (calendula), isoamyl laurate, coco-caprylate, viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, allantoin, panthenol.
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 activity in the water
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.SPF30 CALENDULA SUNSCREEN TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE Water isoamyl laurate coco-caprylate calendula officinalis flower VIOLA TRICOLOR WHOLE polyglyceryl-2 dipolyhydroxystearate CANDELILLA WAX STARCH, RICE CARTHAMUS TINCTORIUS SEED OLEOSOMES polyglyceryl-3 diisostearate levulinic acid MEDIUM-CHAIN TRIGLYCERIDES STARCH, TAPIOCA ROSEMARY COCONUT OIL squalane magnesium stearate p-anisic acid allantoin CLARY SAGE OIL TEA TREE OIL LAVENDER OIL GARDENIA TAITENSIS FLOWER panthenol
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 - 82 g Tube Label CALIF♥RNIA BABY ® TRUSTED SINCE 1995 calendula™ 30+ SUNSCREEN LOTION HIGH PROTECTION SUPER GENTLE & SOOTHING BROAD SPECTRUM SPF 30+ SUNSCREEN WATER RESISTANT (80 MINUTES) FOR BABIES, KIDS + ADULTS WITH SENSITIVE SKIN ALLERGY TESTED © 2018 NET WT 82 g/2.9 oz. Principal Display Panel - 82 g Tube 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
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016
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. Stop use and ask a doctor if rash or irritation develops and lasts. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If 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