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Softlips raspberry - Medication Information

Product NDC Code 10742-8470
Drug Name

Softlips raspberry

Type Brand
Pharm Class Skin Barrier Activity [PE]
Active Ingredients
Dimethicone 20 mg/g
Octinoxate 75 mg/g
Octisalate 30 mg/g
Oxybenzone 30 mg/g
Route TOPICAL
Dosage Form OINTMENT
Application Number part352
Labeler Name The Mentholatum Company
Packages
Package NDC Code Description
10742-8470-1 1 tube in 1 blister pack (10742-8470-1) / 2 g in 1 tube
10742-8470-9 2 tube in 1 blister pack (10742-8470-9) / 2 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Dimethicone 2% Octinoxate 7.5% Octisalate 3% Oxybenzone 3%

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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, flavor, myristyl alcohol, BHT, camellia sinensis (green tea) leaf extract, carthamus tinctorius (safflower) seed oil, menthol, oenothera biennis (evening primrose) oil, punica granatum (pomegranate) seed extract, tocopheryl acetate [vitamin E]

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 temporarily protects chapped or cracked lips

Purpose

Information about the drug product’s indications for use.
Purpose Dimethicone - Skin protectant Octinoxate - Sunscreen Octisalate - Sunscreen Oxybenzone - Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Softlips Raspberry dimethicone, octinoxate, octisalate, oxybenzone CERESIN SQUALANE ETHYLHEXYL PALMITATE PETROLATUM MYRISTYL MYRISTATE MYRISTYL LACTATE CETYL ALCOHOL MYRISTYL LAURATE MYRISTYL ALCOHOL BUTYLATED HYDROXYTOLUENE GREEN TEA LEAF SAFFLOWER OIL MENTHOL, UNSPECIFIED FORM EVENING PRIMROSE OIL POMEGRANATE SEED .ALPHA.-TOCOPHEROL DIMETHICONE DIMETHICONE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE OXYBENZONE OXYBENZONE

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.
Package/Label Principal Display Panel Softlips Raspberry Package/Label Principal Display Panel Drug Facts

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? Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

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 condition worsens symptoms last more than 7 days or clear up and occur again within a few days

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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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. Stop use and ask a doctor if rash occurs condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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