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| Product NDC Code | 11344-947 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sunscreen for babies spf 50 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Consumer Product Partners, LLC | ||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse reaction Distributed by: Consumer Product Partners, LLC ST. Louis MO 63114 1-888-593-0593
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3% Homosalate 12% Octisalate 5%
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 liberaly 15 minutes before sun exposure apply to all skin exposed to the sun reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especialy from 10 a.m. -2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol
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 rist 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.Sunscreen for Babies SPF 50 Avobenzone, Homosalate, Octisalate WATER DIETHYLHEXYL 2,6-NAPHTHALATE BUTYLOCTYL SALICYLATE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) ALUMINUM STARCH OCTENYLSUCCINATE ALOE VERA LEAF GLYCERIN POLYESTER-7 SILICON DIOXIDE CHLORPHENESIN BENZYL ALCOHOL ARACHIDYL ALCOHOL CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) NEOPENTYL GLYCOL DIHEPTANOATE DOCOSANOL TOCOPHEROL YELLOW WAX ARACHIDYL GLUCOSIDE POTASSIUM HYDROXIDE GLYCERYL MONOSTEARATE PEG-100 STEARATE EDETATE DISODIUM ANHYDROUS SODIUM ASCORBYL PHOSPHATE .ALPHA.-HEXYLCINNAMALDEHYDE ISOMETHYL-.ALPHA.-IONONE GERANIOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE
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 SPF 50 SOLAR PLEX ® SUNSCREEN LOTION FOR BABIES Broad Spectrum SPF 50 Water resistant (80 minutes) With Aloe and Vitamin E Oxybenzone, Octinoxate, Octocrylene and Dye free Compare to Coppertone ® Sunscreen Lotion Water Babies ® Broad Spectrum SPF 50* 8 FL OZ (236 mL) image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Disclaimer May stain or damage some fabrics or surfaces *This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Lotion Water Babies ® Broad Spectrum SPF 50.
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 right away.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container 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
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