FDA.reportPublic FDA data

Massage cream for stretch marks

Product NDC
84509-005
11-digit product format
845090005
Labeler code
84509
Product ID
84509-005_2b3ee40e-8b4e-10b4-e063-6394a90a8a82
Type
HUMAN OTC DRUG
Nonproprietary name
Helianthus Annuus (Sunflower) Seed 0il,Butyrospermum Parkii (Shea) Buter,Argania Spinosa Kernel 0il,Tocopherol,Centella Asiatica Extract,Ceramide NP,Soluble Collagen,Hydrolyzed Elastin,Prunus Amygdalus Dulcis (Sweet Almond) Oil
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
Substance
COLLAGEN, SOLUBLE, FISH SKIN; SUNFLOWER OIL; ALMOND OIL; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); SHEA BUTTER; ARGAN OIL; TOCOPHEROL; CENTELLA ASIATICA TRITERPENOIDS; CERAMIDE NP
Active strength
100; 5000; 2000; 100; 4000; 2000; 2000; 2000; 100 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Massage cream for stretch marks
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLLAGEN, SOLUBLE, FISH SKIN100 mg/100mL
SUNFLOWER OIL5000 mg/100mL
ALMOND OIL2000 mg/100mL
HYDROLYZED BOVINE ELASTIN (BASE100 mg/100mL
1000 MW)4000 mg/100mL
SHEA BUTTER2000 mg/100mL
ARGAN OIL2000 mg/100mL
TOCOPHEROL2000 mg/100mL
CENTELLA ASIATICA TRITERPENOIDS100 mg/100mL
CERAMIDE NP

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8JC99XGU4WInternal UNII lookup
3W1JG795YIInternal UNII lookup
66YXD4DKO9Internal UNII lookup
K49155WL9YInternal UNII lookup
4V59G5UW9XInternal UNII lookup
R0ZB2556P8Internal UNII lookup
4YS74Q4G4JInternal UNII lookup
4370DF050BInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1dce7cf1-1fb8-e14e-e063-6394a90ae34aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
84509-005-01Massage cream for stretch marks100 mL in 1 BOTTLECREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-005MASSAGE CREAM FOR STRETCH MARKS (HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL) CREAM [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]3Current NDC, 1 package rows20250110_1dce7cf1-1fb8-e14e-e063-6394a90ae34a.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 29 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrueLipids Relieve and Protect CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c0af9b-f397-dec3-e063-6394a90aed8b2025-12-15WarningsExact identifier
application number: M016
Truelipids TrueLips Lip Balm CL MDWHITE PETROLATUMClaridei Laboratories, Inc.27c155dc-f194-6750-e063-6394a90a20b12025-12-15WarningsExact identifier
application number: M016
Aquaphor HealingPETROLATUMBeiersdorf Inc0a17bf6f-6114-4647-a509-65999255c37b2025-12-15WarningsExact identifier
application number: M016
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
application number: M016
Aquaphor Healing Diaper RashZINC OXIDEBeiersdorf Incdec07dfc-67a2-46ad-8fab-828488bdba152025-12-15WarningsExact identifier
application number: M016
HealthWise Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare7ba0ac53-c78c-4a70-a977-a082f731919e2025-12-15WarningsExact identifier
application number: M016
Aquaphor Lip Protectant and SunscreenPETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBeiersdorf Inca43c2802-9cf1-477e-9f93-e11cf40b480d2025-12-15WarningsExact identifier
application number: M016
Prequel Barrier Therapy Rich Skin Protectant CreamSKIN PROTECTANT CREAMThe Center Brands, LLC39945806-8f29-020b-e063-6294a90a9fc62025-12-13WarningsExact identifier
application number: M016
ECZEMACOLLOIDAL OATMEALSmith Amish, LLC20c4bc16-ba20-47ec-e063-6394a90a8b4e2025-12-12WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEHumco Holding Group, Inc.8c43590d-56ec-4588-8076-99ba94a166852025-12-11WarningsExact identifier
application number: M016
Soteri Skin Baby Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d88ff2-22aa-8447-e063-6294a90aea0e2025-12-10WarningsExact identifier
application number: M016
Soteri Skin Active Flare-Up Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc.41b558d9-55ba-97ff-e063-6394a90a963b2025-12-10WarningsExact identifier
application number: M016
CeraVe Developed With Dermatologist Baby Eczema Relief CreamOATMEALL'Oreal USA Products Inc5d392529-9f0c-40bc-92ca-7003f8e64b1c2025-12-09WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-005-0184509000501100 mL in 1 BOTTLE (84509-005-01) 100 ml2024-07-22NoNoCurrent