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Product NDC Code | 0299-4118 | ||||||||
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Drug Name | Cetaphil healthy radiance whipped day cream broad spectrum spf 30 |
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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.....Purpose Avobenzone 3% .................Sunscreen Homosalate 12.5% .........… Sunscreen Octisalate 5% ...............… Sunscreen Octocrylene 8% ................. Sunscreen
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 use a water resistant sunscreen if swimming or sweating reapply 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 may stain or damage some fabrics
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, C12-15 Alkyl Benzoate, Butylene Glycol, Isododecane, Sorbitol, Silica, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Niacinamide, Glycerin, Phenoxyethanol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Phenylethyl Resorcinol, Carbomer, Fatty Acid Ethoxylate, Sorbitan Stearate, Synthetic Fluorphlogopite, Ethylhexylglycerin, Titanium Dioxide, Disodium EDTA, Sodium Hydroxide, Tin Oxide
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.OTC - PURPOSE SECTION
Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30 avobenzone, homosalate, octisalate, octocrylene Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Water Alkyl (C12-15) Benzoate Butylene Glycol Isododecane Sorbitol Silicon Dioxide Styrene/Acrylamide Copolymer (500000 Mw) Cetostearyl Alcohol Niacinamide Glycerin Phenoxyethanol Dimethicone Glyceryl Monostearate Peg-100 Stearate Polyoxyl 20 Cetostearyl Ether Phenylethyl Resorcinol Carbomer Homopolymer, Unspecified Type Sorbitan Monostearate Magnesium Potassium Aluminosilicate Fluoride Ethylhexylglycerin Titanium Dioxide Edetate Disodium Anhydrous Sodium Hydroxide Stannic Oxide P54853-1 Healthy Radiance Whipped Day Cream SPF 30 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 - 3 FL OZ Carton #1 Doctor Recommended Sensitive Skincare Brand Cetaphil® HEALTHY RADIANCE Whipped Day Cream Broad Spectrum SPF 30 Helps even skin tone while protecting, hydrating and firming skin GentleBright Complex with Niacinamide Five Skin Sensitivity Signs NET WT 1.7 OZ (48 g) Distributed by: Galderma Laboratories, L.P., Fort Worth, TX 76177 USA All trademarks are the property of their respective owners. Cetaphil.com P54853-1
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