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| Product NDC Code | 63940-086 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Harmon face values refreshing cooling body mist sunscreen spf 45 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | AEROSOL, SPRAY | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | HARMON STORES, INC. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0%, Homosalate, 15.0%, Octisalate 5.0%, Octocrylene 2.35%
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 Spray liberally and spread evenly by hand 15 minutes before sun exposure Hold can 4-6 inches away from skin to apply Do not spray into face. Spray into hand and apply to face. Use in well ventilated area 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 alcohol denat., tridecyl salicylate, diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, dimethicone, trisiloxane, PPG-5-ceteth-20, cyclopentasiloxane, propylene glycol, menthyl lactate, ethoxydiglycol, acrylates/dimethicone copolymer, retinyl palmitate, phospholipids, fragrance, tocopheryl acetate, ascorbyl palmitate, water, beta-carotene.
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.HARMON FACE VALUES REFRESHING COOLING BODY MIST SUNSCREEN SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ALCOHOL DIETHYLHEXYL 2,6-NAPHTHALATE DIMETHICONE TRISILOXANE PPG-5-CETETH-20 .ALPHA.-TOCOPHEROL ACETATE ASCORBYL PALMITATE VITAMIN A PALMITATE CYCLOMETHICONE 5 MENTHYL LACTATE, (-)- WATER LECITHIN, SOYBEAN BETA CAROTENE PROPYLENE GLYCOL DIETHYLENE GLYCOL MONOETHYL ETHER HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) TRIDECYL SALICYLATE
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.Label 42074D6
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.
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. Keep out of 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 may stain or damage some fabrics, materials or surfaces
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. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.
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