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Slmd moisturizer with spf - Medication Information

Product NDC Code 59958-403
Drug Name

Slmd moisturizer with spf

Type Brand
Active Ingredients
Avobenzone 2.5 g/100g
Octinoxate 7.5 g/100g
Octisalate 1.5 g/100g
Oxybenzone 3.5 g/100g
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Owen Biosciences, Inc.
Packages
Package NDC Code Description
59958-403-01 1 bottle, pump in 1 package (59958-403-01) / 60 g in 1 bottle, pump
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Octinoxate 7.50% Oxybenzone 3.50% Avobenzone 2.50% Octisalate 1.50%

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.
topical sunscreen

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water Emulsifying Wax NF Cetyl Alcohol Glycerin DEA-Cetyl Phosphate Dimethicone Behentrimonium Methosulfate Cetearyl Alcohol Myristoyl Pentapeptide-17 Myristoyl Tetrapeptide-13 Ascorbyl Linoleate Retinyl Linoleate Lysophosphatidic acid Panthenol Allantoin Arginine Beta-Glucan Sodium Carboxymethyl Beta-Glucan Ethyl Macadamiate Borago Officinalis Seed Oil Triticum Vulgare (Wheat) Germ Oil Tocopheryl Acetate Retinyl Palmitate Citrus Paradisi (Grapefruit) Fruit Extract Camellia Sinensis Leaf Extract Rosa Canina Fruit Extract Hamamelis Virginiana (Witch Hazel) Extract Polyglyceryl-3 Polyricinoleate Polyglyceryl 5 Oleate PPG-2 Myristyl Ether Propionate Pentaerythrityl Tetracaprylate/Tetracaprate Disodium EDTA Caprylyl Glycol Phenoxyethanol

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.
sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
SLMD Moisturizer with SPF Sunscreen WATER CETYL ALCOHOL GLYCERIN CETYL PHOSPHATE DIMETHICONE BEHENTRIMONIUM METHOSULFATE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE AVOBENZONE AVOBENZONE 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.
Daily Moisturizer Back.jpg Daily Moisturizer Back.jpg Daily Moisturizer Back.jpg

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Stop us and ask a doctor if irritation becomes severe

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.

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 in this containerfrom excessive heat and direct sun may stain some fabrics

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.
Directions apply liberally and evenly 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating: immediately after towel drying at least every two 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 thsi 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

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. skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

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