SUNDAY RILEY U.F.O ACNE TREATMENT FACE OIL- salicylic acid oil

SUNDAY RILEY U.F.O Acne Treatment Face Oil by

Drug Labeling and Warnings

SUNDAY RILEY U.F.O Acne Treatment Face Oil by is a Otc medication manufactured, distributed, or labeled by Sunday Riley Modern Skincare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 

PACKAGE LABEL NDC:

73001-460-05

INGREDIENTS AND APPEARANCE

SUNDAY RILEY U.F.O ACNE TREATMENT FACE OIL 
salicylic acid oil

Product 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)