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Sunscreen stick - Medication Information

Product NDC Code 82953-006
Drug Name

Sunscreen stick

Type Brand
Active Ingredients
Avobenzone 1.5 g/100g
Homosalate 4 g/100g
Octisalate 2 g/100g
Octocrylene 4 g/100g
Route TOPICAL
Dosage Form STICK
Application Number part352
Labeler Name Cosmuses Cosmetics (Ningbo) Co., Ltd.
Packages
Package NDC Code Description
82953-006-01 14 g in 1 cylinder (82953-006-01)
82953-006-02 15 g in 1 cylinder (82953-006-02)
82953-006-03 2 g in 1 cylinder (82953-006-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Avobenzone 1.5% Homosalate 4% Octisalate 2% Octocrylene 4%

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 15-20 minutes before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Children under 6 months of age: ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Paraffinum liquidum, Petrolatum, Ozokerite, Ethylhexyl Palmitate, beeswax, Microcrystalline Wax, Phenoxyethanol, Fragrance, BHT

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.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Sunscreen stick avobenzone, homosalate, octisalate, octocrylene OCTOCRYLENE OCTOCRYLENE MINERAL OIL CERESIN BUTYLATED HYDROXYTOLUENE ETHYLHEXYL PALMITATE MICROCRYSTALLINE WAX PHENOXYETHANOL PETROLATUM YELLOW WAX 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.
82953-006

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.
Drug facts

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 call a Poison Control Center right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other information: Store at 20-25 o C (68-77 o F).

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