FDA.reportPublic FDA data

Stretch Marks cream

Product NDC
84509-006
Requested package NDC
84509-006-01
11-digit product format
845090006
Labeler code
84509
Product ID
84509-006_2b3ee23f-681d-fbb1-e063-6394a90a017d
Type
HUMAN OTC DRUG
Nonproprietary name
Sesamum Indicum (Sesame) Seed Extract,Prunus Persica (Peach) Resin Extract,Sterculia Urens Gum,Tripeptide-1,Hexapeptide-9,Acetyl Tetrapeptide-9,Palmitoyl Pentapeptide-4,Palmitoyl Tetrapeptide-7,Acetyl Hexapeptide-8.
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-31
Substance
STERCULIA URENS WHOLE; ACETYL HEXAPEPTIDE-8; PREZATIDE; PALMITOYL TETRAPEPTIDE-7; ACETYL TETRAPEPTIDE-9; SESAME SEED; HEXAPEPTIDE-9; PALMITOYL PENTAPEPTIDE-4; PEACH
Active strength
1500; 1000; 1000; 1000; 1000; 1500; 1000; 1000; 1500 mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL; mg/50mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Fruit Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
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
Stretch Marks cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STERCULIA URENS WHOLE1500 mg/50mL
ACETYL HEXAPEPTIDE-81000 mg/50mL
PREZATIDE1000 mg/50mL
PALMITOYL TETRAPEPTIDE-71000 mg/50mL
ACETYL TETRAPEPTIDE-91000 mg/50mL
SESAME SEED1500 mg/50mL
HEXAPEPTIDE-91000 mg/50mL
PALMITOYL PENTAPEPTIDE-41000 mg/50mL
PEACH1500 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2XCT0M29LMInternal UNII lookup
L4EL31FWILInternal UNII lookup
39TG2H631EInternal UNII lookup
Q41S464P1RInternal UNII lookup
VMO8OOD3V0Internal UNII lookup
7Y1255HVXRInternal UNII lookup
L25414IE41Internal UNII lookup
KK181SM5JGInternal UNII lookup
3OKE88I3QGInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e827483-259a-d12f-e063-6394a90a7885Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-006-01Stretch Marks cream50 mL in 1 BOTTLECREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-006STRETCH MARKS CREAM (SESAMUM INDICUM (SESAME) SEED EXTRACT,PRUNUS PERSICA (PEACH) RESIN EXTRACT,STERCULIA URENS GUM,TRIPEPTIDE-1,HEXAPEPTIDE-9,ACETYL TETRAPEPTIDE-9,PALMITOYL PENTAPEPTIDE-4,PALMITOYL TETRAPEPTIDE-7,ACETYL HEXAPEPTIDE-8.) CREAM [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]4Current NDC, 1 package rows20250110_1e827483-259a-d12f-e063-6394a90a7885.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 47 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TURMERICFaceCreamNIACINAMIDEShengnan (Guangzhou) Cosmetics Co., LTD2b0652be-a216-d66b-e063-6394a90a0b282025-01-06WarningsExact identifier
application number: M016
Menthol and Zinc OxideMENTHOL AND ZINC OXIDEGERI-GENTLE CORPORATIONe673d8bd-2573-9f04-e053-2995a90a172a2025-01-06WarningsExact identifier
application number: M016
ClearSoothingCreamHYALURONIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD2ac88f9a-a41b-1978-e063-6394a90a24212025-01-03WarningsExact identifier
application number: M016
MILKBODyLotionUREAShengnan (Guangzhou) Cosmetics Co., LTD2ac99028-a811-9332-e063-6294a90aee5c2025-01-03WarningsExact identifier
application number: M016
Royal Jelly Scar BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.27be84c1-0227-41ca-beb6-3855eff77e412025-01-02WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
application number: M016
Badger DiaperZINC OXIDEW.S. Badger Company, Inc.674542b2-33fb-4664-857d-4ff1d7f768a02024-12-31WarningsExact identifier
application number: M016
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
application number: M016
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
application number: M016
SkinCeuticals Advanced Scar Control Skin ProtectantALLANTOINL'Oreal USA Products Inc83f4bfbb-47d8-4fe9-ba33-85142ec6221c2024-12-28WarningsExact identifier
application number: M016
Personal Cleansing with DimethiconeDIMETHICONECardinal Health 200, Inc3f9a1a90-ab12-4911-b8c2-df200b0dde5b2024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT NUDEZINC OXIDEBentley Laboratories, LLCa35ae585-f899-4c7e-8cd2-c0b2fe6a20782024-12-27WarningsExact identifier
application number: M016
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TANZINC OXIDEBentley Laboratories, LLC7920708a-6fa7-4bc8-94ba-096e77d9d7e12024-12-27WarningsExact identifier
application number: M016
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure Recovery SystemALUMINUM ACETATEZO Skin Health, Inc.3b977415-2bf4-43a9-bb48-1eb023ca4f532024-12-27WarningsExact identifier
application number: M016
terrasil Scar RecoveryALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2a2f91ff-a447-9d2a-e063-6394a90a84f82024-12-26WarningsExact identifier
application number: M016
WITCH HAZELWITCH HAZELCHAIN DRUG MARKETING ASSOCIATION INCbdccee3f-0ad8-4264-a65f-ae86aed6bf032024-12-26WarningsExact identifier
application number: M016
All Over Lavender RosemaryCOLLOIDAL OAT OINTMENTTubby Todd29f46671-7467-95c9-e063-6294a90a13542024-12-23WarningsExact identifier
application number: M016
Sweet Cheeks Diaper SprayerZINC OXIDE DIAPER PASTE SPRAYTubby Todd29f4aa3c-d10e-52a5-e063-6294a90acc4b2024-12-23WarningsExact identifier
application number: M016
calamineCALAMINE AND ZINC OXIDEWALGREEN COMPANYfed3026b-3473-26fe-e053-6294a90a8aa22024-12-23WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-006-018450900060150 mL in 1 BOTTLE (84509-006-01) 50 ml2024-07-31NoNoCurrent