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| Product NDC Code | 55910-726 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 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 | CREAM | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | OLD EAST MAIN CO. | ||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adversation reaction DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
Active ingredient
A list of the active, medicinal ingredients in the drug product.active ingredients Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%
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 Directions ■ apply liberally 15 minutes before sun exposure ■ reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel dryin g ■ at least every 2 hours ■ 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 ■ children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients water, butyloctyl salicylate, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, propanediol, triacontanyl PVP, cetearyl alcohol, PEG-100 stearate, cetearyl glucoside, glyceryl behenate, dimethicone, glycerin, PEG-150/decyl alcohol/SMDI copolymer, Aloe barbadensis leaf juice, allantoin, panthenol, tocopheryl acetate, triethoxycaprylylsilane, fragrance, phenoxyethanol, methylisothiazolinone, tetrasodium EDTA
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 skin 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.Sunscreen Octinoxate, Octisalate, Zinc oxide OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE ZINC OXIDE ZINC CATION OCTOCRYLENE OCTOCRYLENE WATER BUTYLOCTYL SALICYLATE ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOSTEARATE PROPANEDIOL TRICONTANYL POVIDONE CETOSTEARYL ALCOHOL PEG-100 STEARATE CETEARYL GLUCOSIDE GLYCERYL DIBEHENATE DIMETHICONE GLYCERIN PEG-150/DECYL ALCOHOL/SMDI COPOLYMER (1350 MPA.S AT 3%) ALOE VERA LEAF ALLANTOIN PANTHENOL .ALPHA.-TOCOPHEROL ACETATE triethoxycaprylylsilane PHENOXYETHANOL METHYLISOTHIAZOLINONE EDETATE SODIUM
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 STUDIO SELECTION SUN CLEAR ZINC SUNSCREEN BROAD SPECTRUM SPF 50 Water-Resistant (80 minutes) For face, nose or ears Paraben Free SPF 50 NET WT 1 OZ (28.3 g) image description
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.claims CLEAR ZINC SUNSCREEN BROAD SPECTRUM SPF 50 Dermatologist-Tested • UVA/UVB Protection Goes on Clear • With Aloe and Vitamin E
Other information protect the product from excessive heat and direct sun
claims May stain or damage some fabrics or surfaces
disclaimer This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Spray Sport Broad Spectrum SPF 70 DSP-TN-15000 DSP-MO-34 SDS-TN-15012 100% Satisfaction Guaranteed! (888)309-9030
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 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. 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.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