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| Product NDC Code | 68828-444 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Tender moments baby sunscreen broad spectrum spf 50 water resistant (40 minutes) |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Jafra Cosmetics International | ||||||||
| 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 Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen Octocrylene 10% 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 reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: 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 your 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 Water/Aqua, Glycerin, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ethylhexyl Methoxycrylene, Mica/CI 77019, Silica, Bisabolol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Tocopheryl Acetate, Chlorphenesin, Disodium 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.Stop use and ask a doctor if rash occurs.
Purpose
Information about the drug product’s indications for 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.
Spl product data elements
Usually a list of ingredients in a drug product.Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) Avobenzone, Homosalate, Octisalate, Octocrylene POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) VINYLPYRROLIDONE/EICOSENE COPOLYMER HEXYLENE GLYCOL MICA PHENOXYETHANOL CAPRYLYL GLYCOL WATER CETYL ALCOHOL DICAPRYLYL CARBONATE ETHYLHEXYL METHOXYCRYLENE ETHYLHEXYLGLYCERIN SILICON DIOXIDE LEVOMENOL SHEA BUTTER ALOE VERA LEAF CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) PANTHENOL .ALPHA.-TOCOPHEROL ACETATE CHLORPHENESIN EDETATE DISODIUM ANHYDROUS ARGININE GLYCERYL MONOSTEARATE PEG-100 STEARATE GLYCERIN AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Product label image description
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 product is 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 this product from excessive heat and direct sun
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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove
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