FDA.reportPublic FDA data

THERA Moisturizing Body Shield

Product NDC
68599-0204
11-digit product format
685990204
Labeler code
68599
Product ID
68599-0204_1b291acd-e2c4-bcca-e063-6294a90a3a91
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
McKesson Medical-Surgical Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-01
Substance
DIMETHICONE
Active strength
15 mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
THERA Moisturizing Body Shield
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309917Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56869b64-11ee-4df6-8102-ce5818e0116eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0204-1THERA Moisturizing Body Shield4 g in 1 PACKETCREAM45
68599-0204-1THERA Moisturizing Body Shield144 in 1 CARTONCREAM1445
68599-0204-4THERA Moisturizing Body Shield113 g in 1 TUBECREAM1135

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUATHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
KUKUI NUTINACTIVE INGREDIENTJ87WJ3E7VWTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PROPYLHEPTYL CAPRYLATEINACTIVE INGREDIENT991Z19V2ODTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0204THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]5Current NDC, Legacy NDC, 3 package rows20240619_56869b64-11ee-4df6-8102-ce5818e0116e.zip

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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309917dimethicone 1.5 % Topical CreamPSN56869b64-11ee-4df6-8102-ce5818e0116e5
309917dimethicone 15 MG/ML Topical CreamSCD56869b64-11ee-4df6-8102-ce5818e0116e5
309917dimethicone 1.5 % Topical CreamSY56869b64-11ee-4df6-8102-ce5818e0116e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0204-168599020401144 PACKET in 1 CARTON (68599-0204-1) / 4 g in 1 PACKET144 packet2011-09-010000-00-00NoNoCurrent
68599-0204-468599020404113 g in 1 TUBE (68599-0204-4) 113 g2011-09-010000-00-00NoNoCurrent