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| Product NDC Code | 62742-4232 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf elio drops 30 sheer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Allure Labs 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 INGREDIENTS - ZINC OXIDE 15.6%
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 FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. 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 SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING AT LEAST EVERY 2 HOURS.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/ CAPRATE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, LECITHIN, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, PRUNUS ARMENIACA KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENESIS LEAF EXTRACT, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL
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.SPF Elio Drops 30 Sheer Zinc Oxide ISODODECANE ARGAN OIL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) LEVOMENOL SQUALANE POLYGLYCERYL-3 PENTARICINOLEATE TETRAHEXYLDECYL ASCORBATE PISTACIA LENTISCUS RESIN OIL ZINC OXIDE ZINC OXIDE PROPANEDIOL DICAPRYLATE/CAPRATE APRICOT KERNEL OIL POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE LECITHIN, SOYBEAN SAFFLOWER OIL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE GINGER CAMELLIA OIL
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.SPFEliodrops30sheer
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.DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS
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 THE REACH OF CHILDREN IF 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.OTHER INFORMATION:PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN
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 SEVERE IRRITATION OCCURS
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. IF CONTACT OCCURS, RINSE WITH WATER.
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
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