FDA.reportPublic FDA data

DayTime Moisturizer

Manufacturer
SGII, INC | 220 LABORATORIES INC
Effective date
2020-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:29:34

Label at a glance#

ProductDayTime Moisturizer
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Keep out of eyes

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245199salicylic acid 1 % Topical LotionPSN1
245199salicylic acid 10 MG/ML Topical LotionSCD1
245199salicylic acid 1 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72644-633-012024-07-30C16284748780-11030e364-ff27-111a-e063-dadaa90a10e2Daytime Moisturizer
72644-633-012024-01-30C16284748780-11030e364-ff27-111a-e063-dadaa90a10e2Daytime Moisturizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72644-633-01DayTime Moisturizer27 g in 1 BOTTLELOTION271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72644-633DAYTIME MOISTURIZER (SALICYLIC ACID) LOTION [SGII, INC]1Legacy NDC, 1 package rows20200917_af727835-980d-5af0-e053-2a95a90a5ad7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72644-63372644-633-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 52 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM METABISULFITE4VON5FNS3CIACT
GINGERC5529G5JPQIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
LEVOMENOL24WE03BX2TIACT
LAMINARIA DIGITATA15E7C67EE8IACT
TOCOPHEROLR0ZB2556P8IACT
PANTHENOLWV9CM0O67ZIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CAESALPINIA SPINOSA RESINWL3883U2POIACT
CETYL PALMITATE5ZA2S6B08XIACT
OCTINOXATE4Y5P7MUD51IACT
OLIVE OIL6UYK2W1W1EIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
PREZATIDE39TG2H631EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SHEA BUTTERK49155WL9YIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
AVOCADO OIL6VNO72PFC1IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
GLYCERINPDC6A3C0OXIACT
GLYCERETH-26NNE56F2N14IACT
JOJOBA OIL724GKU717MIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
CUCUMBER JUICE61845009SPIACT
ARGININE94ZLA3W45FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
UREA8W8T17847WIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af727835-980e-5af0-e053-2a95a90a5ad7af727835-980d-5af0-e053-2a95a90a5ad72020-09-16WarningsExact identifier
spl id: af727835-980e-5af0-e053-2a95a90a5ad7
spl set id: af727835-980d-5af0-e053-2a95a90a5ad7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.