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.

  • Drug Facts

  • Active Ingredient

    Salicylic Acid 1.5%

  • Purpose

    Acne treatment

  • Uses

    • For the management of acne

    • Penetrates pores to control blackheads

    • Helps prevent new acne blemishes and blackheads from forming

  • 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.

  • 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 

    Ufo-nw

  • PACKAGE LABEL NDC 73001-460-05

    image description

  • INGREDIENTS AND APPEARANCE
    SUNDAY RILEY U.F.O ACNE TREATMENT FACE OIL 
    salicylic acid oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73001-460
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73001-460-151 in 1 BOX04/30/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73001-460-051 in 1 BOX04/30/2017
    25 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/30/2017
    Labeler - Sunday Riley Modern Skincare, LLC (012302640)