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| Product NDC Code | 73001-460 | ||||||
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| Drug Name | Sunday riley u.f.o acne treatment face oil |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OIL | ||||||
| RxCUI drug identifier | 2170987 | ||||||
| Application Number | part333D | ||||||
| Labeler Name | Sunday Riley Modern Skincare, LLC | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Salicylic Acid 1.5%
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 • Cleanse the skin thoroughly before applying medication. • Cover the entire affected area with a thin layer 1 to 3 times daily. • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor. • If bothersome dryness occurs, reduce application to once a day or every other day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Silybum Marianum (Milk Thistle) Seed Oil, Nigella Sativa (Black Cumin) Seed Oil, Cucumis Sativus (Cucumber) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Diisopropyl Sebacate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Dimethyl Isosorbide, Linum Usitatissimum (Flax) Seed Oil, Caprylic/Capric Triglyceride, Glycyrrhiza Glabra (Licorice) Root Extract, Prunus Armeniaca (Apricot) Kernel Oil, Hexylresorcinol, Ethyl Linoleate, Melia Azadirachta Leaf Extract, Chamomilla Recutita (Matricaria) Flower Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Melia Azadirachta (Neem) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, 4-Terpineol, Linalool, Coccinia Indica Fruit Extract, Limonene, Solanum Melongena (Eggplant) Fruit Extract, Amber Powder, Curcuma Longa (Turmeric) Root Extract, Ocimum Sanctum Leaf Extract, Isopropyl Alcohol, Aloe Barbadensis (Aloe) Flower Extract, Corallina Officinalis Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Moringa Oleifera Seed Oil, Tocopherol, Farnesol, Geraniol, Aqua, Citrus Paradisi (Grapefruit) Peel Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract.
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 • For the management of acne • Penetrates pores to control blackheads • Helps prevent new acne blemishes and blackheads from forming
Purpose
Information about the drug product’s indications for use.Purpose Acne treatment
Spl product data elements
Usually a list of ingredients in a drug product.SUNDAY RILEY U.F.O Acne Treatment Face Oil Salicylic Acid SALICYLIC ACID SALICYLIC ACID SILYBUM MARIANUM SEED OIL NIGELLA SATIVA SEED OIL CUCUMBER SEED OIL POMEGRANATE SEED OIL DIISOPROPYL SEBACATE CRANBERRY SEED OIL DIMETHYL ISOSORBIDE LINSEED OIL MEDIUM-CHAIN TRIGLYCERIDES GLYCYRRHIZA GLABRA APRICOT KERNEL OIL HEXYLRESORCINOL ETHYL LINOLEATE AZADIRACHTA INDICA LEAF CHAMOMILE FLOWER OIL CITRUS AURANTIUM FLOWER OIL AZADIRACHTA INDICA FLOWER SUNFLOWER OIL 4-TERPINEOL, (+/-)- LINALOOL, (+/-)- COCCINIA GRANDIS FRUIT LIMONENE, (+)- EGGPLANT AMBER TURMERIC HOLY BASIL LEAF ISOPROPYL ALCOHOL ALOE VERA FLOWER CORALLINA OFFICINALIS ROSEMARY MORINGA OLEIFERA SEED OIL TOCOPHEROL FARNESOL GERANIOL WATER GRAPEFRUIT OIL OCIMUM BASILICUM FLOWERING TOP
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 NDC 73001-460-15 Ufo-nw
PACKAGE LABEL NDC 73001-460-05 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.Drug Facts
for oily to acne-prone skin ultra-clarifying For the treatment and prevention of acne and blackheads , this 1.5% Salicylic Acid medicated, dry oil clears congested pores for smoother, blemish-free skin With 1.5% Salicylic Acid, this fast-acting, medicated treatment oil clears acne and blackhead-causing buildup and debris from congested pores for smoother, blemish-free skin. Tea tree oil and black cumin seed oil support clear skin, while hexylresorcinol and licorice naturally brighten the appearance of old acne discolorations, for a visibly more even-toned complexion. Non-greasy milk thistle and cucumber seed oil prevent Salicylic Acid from over-drying the skin, while smoothing the appearance of fine lines and wrinkles. Chamomile and neroli soothe stressed, blemish-prone skin. DIRECTIONS: Can be applied day or night. After cleansing skin, massage in U.F.O. to skin, neck, and chest, as needed. U.F.O. is a dry oil and will absorb quickly. Can also be applied to congested areas on the body. PRO TIPS: If you are new to using Salicylic Acid, start by using U.F.O. 3x/week and work your way up to daily use. You can also mix 1-2 drops of U.F.O. into your foundation, before application, giving acne-fighting power to your makeup routine. Made in USA of responsibly sourced domestic and foreign ingredients Dist: Sunday Riley Modern Skincare, LLC Houston, TX 77027 USA EU RP: Obelis s.a., 1030 Brussels, BE www.sundayriley.com
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.
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. When using this product • Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. • If this occurs, only one medication should be used unless directed by a doctor. 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