NATURIUM ENCAPSULATED SALICYLIC ACID MOISTURIZER 0.75%- salicylic acid lotion

Naturium Encapsulated Salicylic Acid Moisturizer 0.75% by

Drug Labeling and Warnings

Naturium Encapsulated Salicylic Acid Moisturizer 0.75% by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid 0.75%

Purpose

Acne Treatment

Uses

• Helps fight existing acne breakouts and prevents future acne breakouts.

Warnings

For external use only.

When using this product

• skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one acne product at a time.
• Avoid eye area. In case of eye contact, flush gently and thoroughly with water. Do not apply to broken or irritated skin.

Keep out of reach of children.

If swallowed, seek medical help.

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.
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and ask a doctor.

Other Information

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Inactive Ingredients

Aqua (Water), Propanediol, Butylene Glycol, Octyldodecanol, Dimethicone, Glyceryl Stearate, Coco-Caprylate/Caprate, Glycerin, Cetearyl Alcohol, Triheptanoin, Octadecenedioic Acid, Silybum Marianum Extract, Magnesium PCA, Amylopectin, Niacinamide, Succinoglycan, Bisabolol, Nelumbo Nucifera Flower Water, Nymphaea Caerulea Flower Water, Palmitic Acid, Lecithin, Physalis Angulata Extract, Acetyl Glucosamine, Castor Oil/IPDI Copolymer, Caprylic/Capric Triglyceride, Dilinoleic Acid/Butanediol Copolymer, Carbomer, C9-12 Alkane, Behenyl Alcohol, Stearic Acid, Dipropylene Glycol, Polysorbate 20, Dextrin, Polydextrose, Caprylyl Glycol, 1,2-Hexanediol, Cetyl Alcohol, Lauryl Alcohol, Myristyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Tocopherol.

Product Packaging

INGREDIENTS AND APPEARANCE

NATURIUM ENCAPSULATED SALICYLIC ACID MOISTURIZER 0.75% 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	7.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
C9-12 ALKANE (UNII: 7J5R5W72QM)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIHEPTANOIN (UNII: 2P6O7CFW5K)
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)
MILK THISTLE (UNII: U946SH95EE)
MAGNESIUM PIDOLATE (UNII: V5PC588N7G)
WATER (UNII: 059QF0KO0R)
AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PALMITIC ACID (UNII: 2V16EO95H1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ICODEXTRIN (UNII: 2NX48Z0A9G)
POLYDEXTROSE (UNII: VH2XOU12IE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECANOL (UNII: 461N1O614Y)
LAURYL ALCOHOL (UNII: 178A96NLP2)
DIMETHICONE (UNII: 92RU3N3Y1O)
LEVOMENOL (UNII: 24WE03BX2T)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
NYMPHAEA CAERULEA FLOWER VOLATILE OIL (UNII: 869334Z0JF)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NELUMBO NUCIFERA FLOWER OIL (UNII: P658Q19EG2)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)
DOCOSANOL (UNII: 9G1OE216XY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-121-01	1 in 1 CARTON	06/17/2022
1		50 g 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 Drug	M006	06/17/2022

Labeler - e.l.f. Cosmetics, Inc (093902816)