DAYTIME MOISTURIZER- salicylic acid lotion 
SGII, 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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Daytime Moisturizer

Active Ingredients

Salicylic Acid 1%

Purpose

Salicylic Acid 1%.......Acne Treatment

Uses

For the treatment of acne.

Warnings

For external use only.

Keep out of eyes

When using this product skin irritation and dryness is more likely 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

Inactive Ingredients

Aqua/Water/Eau, Caprylic/CapricTriglyceride, Cetearyl Alcohol, Glycerin, Glycereth-26, Avocado (Perse
Gratissima) Oil, Jojoba (Simmondsia Chinensis) Seed Oil, Shea (Butyrospermum Parkii) Butter, Cetearyl Olivate, Sorbitan Olivate, Oliv
(Olea Europaea) Fruit Oil, Ammonium Acryloyldimethyltaurate/VP Copolymer, Coffee (Coffea Arabica) Seed Oil, Cucumber (Cucumis
Sativus) Extract, Willow Herb (Epilobium Angustifolium) Extract, Ginge (Zingiber Officinale) Root Extract, Seaweed (Corallina Officinalis) Extract, Kelp (Laminaria Digitata) Extract, Yeast (Saccharomyces Cerevisiae) Extract,

Orchid (Orchis Morio) Flower Extract, Tripeptide-1, Tetrapeptide-17, Tocopherol, Sodium Hyaluronate, Panthenol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Arginine, Dimethicone, Ceteth-10 Phosphate, Dicetyl Phosphate, Hydrolyzed Caesalpinia Spinosa Gum, Benzophenone-3, Ethylhexyl Methoxycinnamate, Cetyl Palmitate, Caprylyl Glycol, Sorbitan Palmitate, Propylene Glycol, Butylene Glycol, Caesalpinia Spinosa Gum, Ethylhexylglycerin, Hexylene Glycol, Bisabolol, Potassium Sorbate, Sodium Benzoate, BHT, Urea*, Glucosamine HCl, Sodium Metabisulfite, Citric Acid, Dextran, Phenoxyethanol, Parfum/Fragrance. *synthetic

PDP

DAYTIME MOISTURIZER 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-633
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
GINGER (UNII: C5529G5JPQ)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
LEVOMENOL (UNII: 24WE03BX2T)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PANTHENOL (UNII: WV9CM0O67Z)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
OCTINOXATE (UNII: 4Y5P7MUD51)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
PREZATIDE (UNII: 39TG2H631E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SHEA BUTTER (UNII: K49155WL9Y)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERETH-26 (UNII: NNE56F2N14)  
JOJOBA OIL (UNII: 724GKU717M)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
CUCUMBER JUICE (UNII: 61845009SP)  
ARGININE (UNII: 94ZLA3W45F)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
UREA (UNII: 8W8T17847W)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DEXTRAN 1 (UNII: I8LHQ0D645)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)  
CORALLINA OFFICINALIS (UNII: 4004498D06)  
ANACAMPTIS MORIO FLOWER (UNII: PT2C4RA48D)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72644-633-0127 g in 1 BOTTLE; Type 0: Not a Combination Product09/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/16/2020
Labeler - SGII, INC (070096792)
Establishment
NameAddressID/FEIBusiness Operations
220 LABORATORIES INC783247950manufacture(72644-633)

Revised: 9/2020
Document Id: af727835-980e-5af0-e053-2a95a90a5ad7
Set id: af727835-980d-5af0-e053-2a95a90a5ad7
Version: 1
Effective Time: 20200916
 
SGII, INC