FDA.reportPublic FDA data

Awaken Moisturizing Cream

Manufacturer
Guangzhou Danting Bath&Body Care Industry Co. Ltd | Medical Group Care, LLC
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:22

Label at a glance#

ProductAwaken Moisturizing Cream
Active ingredientDIMETHICONE
Label structure9 sections

Storage and handling

Store in a cool, dark place

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 5%

OTC - PURPOSE SECTION

Skin Protectant

DOSAGE & ADMINISTRATION SECTION

Skin Protectant

OTC - WHEN USING SECTION

Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

INDICATIONS & USAGE SECTION

Apply liberally as often as needed for supple skin.
Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

STORAGE AND HANDLING SECTION

Store in a cool, dark place

INACTIVE INGREDIENT SECTION

water, glycerin, dimethicone, petrolatum,
caprylic/capric triglyceride, stearic acid, cetearyl
alcohol, ceteareth-20, steareth-2, phenoxyethanol,
acrylates/c10-30 alkyl acrylate crosspolymer, xanthan
gum, tocopheryl acetate, ethylhexylglycerin, sodium
hyaluronate, disodium EDTA, sodium hydroxide,
ceramide NP, ceramide AP, phytosphingosine,
ceramide EOP, polyglyceryl-10
stearate, phytosterols, stearic acid,
pentylene glycol, aspartic acid, sodium
stearoyl glutamate.

WARNINGS SECTION

Avoid direct contact with eyes. If contact occurs rinse
throughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75376-104-16Awaken Moisturizing Cream453 g in 1 BOTTLECREAM4531

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75376-10475376-104-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PETROLATUM4T6H12BN9UIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARETH-20YRC528SWUYIACT
STEARETH-2V56DFE46J5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
XANTHAN GUMTTV12P4NEEIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SODIUM HYALURONATEYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CERAMIDE 15THT33P7X7IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
PENTYLENE GLYCOL50C1307PZGIACT
ASPARTIC ACID30KYC7MIAIIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
DIMETHICONE92RU3N3Y1OACTIB

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
Awaken Moisturizing CreamDIMETHICONEGuangzhou Danting Bath&Body Care Industry Co. Ltd486c7f05-708a-44a1-8fc0-78344f5018db2025-08-21WarningsExact identifier
ndc (package): 75376-104-16
ndc (product): 75376-104
ndc11 (package): 75376010416
spl id: 3ce09ce0-f4bd-96bf-e063-6394a90aae07
spl set id: 486c7f05-708a-44a1-8fc0-78344f5018db

Reported adverse events (FAERS/openFDA)#

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