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| Product NDC Code | 0299-4142 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Cetaphil hydrating face sunscreen spf 35 |
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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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| 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 Avobenzone 2.8% .................Sunscreen Homosalate 9.5% .....................Sunscreen Octisalate 4.8% ..................Sunscreen Octocrylene 7% .................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, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SPL listing data elements section Cetaphil Hydrating Face Sunscreen SPF 35 avobenzone, homosalate, octisalate, octocrylene Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Water Glycerin Dipropylene Glycol Panthenol Ethylhexyl Methoxycrylene Isopropyl Palmitate Silicon Dioxide Niacinamide Cetearyl Olivate Cetostearyl Alcohol Glyceryl Monostearate Potassium Cetyl Phosphate Sorbitan Olivate .Alpha.-Tocopherol Acetate Caprylyl Glycol Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) Palmitic Acid Ethylhexylglycerin Stearic Acid Leontopodium Nivale Subsp. Alpinum Flowering Top 1,2-Hexanediol Rice Germ Propanediol Sodium Hydroxide Adenosine Citric Acid Monohydrate Myristic Acid Tocopherol Buddleja Davidii Leaf Thymus Vulgaris Leaf hydrating face sunscreen
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 NEW DERMATOLOGIST RECOMMENDED FOR SENSITIVE SKIN Cetaphil ® SUN 35 Hydrating Face Sunscreen Broad Spectrum SPF 35 Formulated for sensitive skin Oil-free, lightweight sunscreen hydrates and protects against sun damage Antioxidant Vitamins B3 and E plus Vitamin B5 Skin Cancer Foundation logo 3 FL OZ (88 mL) Distributed by: Galderma Laboratories, L.P. Dallas, Texas 75201 USA All trademarks are the property of their respective owners. cetaphil.com P57554-0
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