Label: SUNDAY RILEY U.F.O ACNE TREATMENT FACE OIL- salicylic acid oil
- NDC Code(s): 73001-460-05, 73001-460-15
- Packager: Sunday Riley Modern Skincare, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 20, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
-
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 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.
-
SPL UNCLASSIFIED SECTION
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
- PACKAGE LABEL NDC 73001-460-15
- PACKAGE LABEL NDC 73001-460-05
-
INGREDIENTS AND APPEARANCE
SUNDAY RILEY U.F.O ACNE TREATMENT FACE OIL
salicylic acid oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73001-460 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength SILYBUM MARIANUM SEED OIL (UNII: NYY23HEN06) NIGELLA SATIVA SEED OIL (UNII: CS4U38E731) CUCUMBER SEED OIL (UNII: AKP926H71P) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) CRANBERRY SEED OIL (UNII: 73KDS3BW5E) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) LINSEED OIL (UNII: 84XB4DV00W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) APRICOT KERNEL OIL (UNII: 54JB35T06A) HEXYLRESORCINOL (UNII: R9QTB5E82N) ETHYL LINOLEATE (UNII: MJ2YTT4J8M) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM) SUNFLOWER OIL (UNII: 3W1JG795YI) 4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6) LINALOOL, (+/-)- (UNII: D81QY6I88E) COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5) LIMONENE, (+)- (UNII: GFD7C86Q1W) EGGPLANT (UNII: W5K7RAS4VK) AMBER (UNII: 70J9Z0J26P) TURMERIC (UNII: 856YO1Z64F) HOLY BASIL LEAF (UNII: SCJ765569P) ISOPROPYL ALCOHOL (UNII: ND2M416302) ALOE VERA FLOWER (UNII: 575DY8C1ER) CORALLINA OFFICINALIS (UNII: 4004498D06) ROSEMARY (UNII: IJ67X351P9) MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0) TOCOPHEROL (UNII: R0ZB2556P8) FARNESOL (UNII: EB41QIU6JL) GERANIOL (UNII: L837108USY) WATER (UNII: 059QF0KO0R) GRAPEFRUIT OIL (UNII: YR377U58W9) OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73001-460-15 1 in 1 BOX 04/30/2017 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:73001-460-05 1 in 1 BOX 04/30/2017 2 5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/30/2017 Labeler - Sunday Riley Modern Skincare, LLC (012302640)