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Product NDC Code | 0299-4110 | ||||||
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Drug Name | Cetaphil sheer mineral face liquid sunscreen spf 50 |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LOTION | ||||||
Application Number | M020 | ||||||
Labeler Name | Galderma Laboratories, L.P. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 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 shake well 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 Other Information ▪ protect the product in this container from excessive heat and direct sun
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients ALLANTOIN, BISABOLOL, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAPRYLYL GLYCOL, CAPRYLYL METHICONE, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISODODECANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, LAURYL PEG-8 DIMETHICONE, NIACINAMIDE, OCTYLDODECYL NEOPENTANOATE, PEG-10, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, PROPANEDIOL, SODIUM CHLORIDE,SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL (VITAMIN E), TRILAURETH-4 PHOSPHATE, WATER
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.Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 zinc oxide Zinc Oxide Zinc Oxide Allantoin Levomenol Butyloctyl Salicylate Alkyl (C12-15) Benzoate Caprylyl Glycol Caprylyl Trisiloxane Dimethicone Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 Mw) Ethylhexylglycerin Hexylene Glycol Isododecane Niacinamide Octyldodecyl Neopentanoate Polyethylene Glycol 500 Phenoxyethanol Polymethylsilsesquioxane (4.5 Microns) Propanediol Sodium Chloride Sodium Hydroxide Tetrasodium Glutamate Diacetate Tocopherol Trilaureth-4 Phosphate Water CETAPHIL SUN SPF 50 LIQ bottleFRONT P55342-1 Cetaphil Sun SPF 50 Liquid Drops 1.7oz carton
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 - 1.7 FL OZ CARTON DERMATOLOGIST RECOMMENDED FOR SENSITIVE SKIN Cetaphil ® SUN 50 Sheer Mineral Face Liquid Sunscreen Broad Spectrum SPF 50 Formulated for sensitive skin 1.7 FL OZ (50 mL) Distributed by: Galderma Laboratories, L.P. Dallas, TX 75201 USA All trademarks are the property of their respective owners. cetaphil.com P55342-1 PRINCIPAL DISPLAY PANEL - 1.7 FL OZ FRONT LABEL Cetaphil ® SUN 50 Sheer Mineral Face Liquid Sunscreen Broad Spectrum SPF 50 Formulated for sensitive skin Microbiome gentle Water resistant (80 minutes) Ideal for use under makeup Vitamin E 1.7 FL OZ (50mL) P55341-1
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-866-735-4137
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