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Habit spf 41 - Prescription Drug Labeling

Product NDC Code 76150-261
Drug Name

Habit spf 41

Type Brand
Active Ingredients
Octisalate 4.9 g/100ml
Avobenzone 2.8 g/100ml
Homosalate 9.8 g/100ml
Octocrylene 9.5 g/100ml
Route TOPICAL
Dosage Form SPRAY
Application Number part352
Labeler Name Bell International Laboratories, Inc
Packages
Package NDC Code Description
76150-261-51 30 ml in 1 bottle, plastic (76150-261-51)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Avobenzone 2.8% Homosalate 9.8% Octisalate 4.9% Octocrylene 9.5% Purpose 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 generously 15 minutes before sun exposure Reapply at least every 2 hours Use a warer-resistant sunscreen if swimming or sweating Reapply after swimming or sweating Children under 6 monts-age: Ask a doctor Sun Protection Meaures. 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 time in the sun, especially from 10a.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 Alcohol Denat., Bisabolol, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Ether, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isononyl Isononanoate, Lavendula Augustifolia (Lavender) Oil, Pelargonium Graveolens Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

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 sunurn 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.
Habit SPF 41 Facial OCTISALATE OCTISALATE BUTYLOCTYL SALICYLATE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DICAPRYLYL ETHER PELARGONIUM GRAVEOLENS FLOWER OIL LEVOMENOL ROSEMARY AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE ETHYL FERULATE ISONONYL ISONONANOATE LAVENDER OIL ALCOHOL DIHEPTYL SUCCINATE

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 Artwork Artwork

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 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 Do not use on damaged or broken skin When using this producty keep out of eyes. Rinse wtih water to remove. Stop use and ask a doctor if rash occurs Flammable. Keep away from fire or spark.

Disclaimer: Do not rely on openFDA 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