SkinCeuticals Silymarin CF Acne Treatment by L'Oreal USA Products Inc / Cosmetic Essence LLC Drug Facts

SkinCeuticals Silymarin CF Acne Treatment by

Drug Labeling and Warnings

SkinCeuticals Silymarin CF Acne Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetic Essence LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINCEUTICALS SILYMARIN CF ACNE TREATMENT- salicylic acid lotion 
L'Oreal USA Products Inc

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.

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Drug Facts

Active ingredient

Salicylic acid  0.5%

Purpose

Acne treatment

Uses

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

Warnings

For external use only

Flammable until dry.

Keep away from flames and heat.

When using this product

skin irritation and dryness is more liekly to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- clean the skin thoroughly before applying this product

- cover the entire affected area with a thin layer one to three times daily

- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

- if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other information

store in a cool, dark place

Inactive ingredients

water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

SKINCEUTICALS SILYMARIN CF ACNE TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
LAURETH-23 (UNII: N72LMW566G)
MILK THISTLE (UNII: U946SH95EE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FERULIC ACID (UNII: AVM951ZWST)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-247-01	1 in 1 CARTON	01/01/2021	01/02/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 49967-247-02	1 in 1 CARTON	01/01/2021	01/02/2021
2		55 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 49967-247-03	1 in 1 CARTON	01/01/2021	01/02/2021
3		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 49967-247-04	4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/01/2021	01/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2021	01/02/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence LLC		032565959	manufacture(49967-247)

Revised: 1/2022

Document Id: 7ff17a38-30a0-43c5-8a25-832e2b67cd55

34390-5

Set id: ff07d2ca-503f-426b-bb5c-2a176563933d

Version: 10

Effective Time: 20220131