FDA.reportPublic FDA data

Body oil for stretch marks

Product NDC
84509-003
Requested package NDC
84509-003-01
11-digit product format
845090003
Labeler code
84509
Product ID
84509-003_2b3ee33c-29bd-6325-e063-6294a90a261a
Type
HUMAN OTC DRUG
Nonproprietary name
Helianthus Annuus (Sunflower) Seed 0il ,Tocopherol,Adansonia Digitata Seed 0il,Moringa Oleifera Seed 0il,Theobroma cacao (Cocoa) Seed Butter,Echium Plantagineum Seed Oil,Sesamum Indicum (Sesame) Seed 0il
Dosage form
OIL
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
Substance
ECHIUM PLANTAGINEUM SEED OIL; MORINGA OLEIFERA SEED OIL; COCOA BUTTER; ADANSONIA DIGITATA SEED OIL; TOCOPHEROL; SUNFLOWER OIL; SESAME OIL
Active strength
1200; 1200; 1200; 1200; 1200; 30000; 1200 mg/60mL; mg/60mL; mg/60mL; mg/60mL; mg/60mL; mg/60mL; mg/60mL
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
Body oil for stretch marks
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ECHIUM PLANTAGINEUM SEED OIL1200 mg/60mL
MORINGA OLEIFERA SEED OIL1200 mg/60mL
COCOA BUTTER1200 mg/60mL
ADANSONIA DIGITATA SEED OIL1200 mg/60mL
TOCOPHEROL1200 mg/60mL
SUNFLOWER OIL30000 mg/60mL
SESAME OIL1200 mg/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PIB7XBU8XWInternal UNII lookup
REM6A5QMC0Internal UNII lookup
512OYT1CRRInternal UNII lookup
77MKL7AR5IInternal UNII lookup
R0ZB2556P8Internal UNII lookup
3W1JG795YIInternal UNII lookup
QX10HYY4QVInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1daeb2e8-f18c-06c3-e063-6294a90a6385Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-003-01Body oil for stretch marks60 mL in 1 BOTTLEOIL603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-003BODY OIL FOR STRETCH MARKS (HELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0IL) OIL [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]3Current NDC, 1 package rows20250110_1daeb2e8-f18c-06c3-e063-6294a90a6385.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 34 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TATWAX VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.333fdce4-5a1d-45a4-94fe-81d47ecd26702025-11-07WarningsExact identifier
application number: M016
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
application number: M016
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
application number: M016
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
application number: M016
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
application number: M016
Pink Eczema CreamCOLLOIDAL OATMEALMOOGOO SKIN CARE PTY LTD3b8d92d0-ab7f-8dd5-e063-6394a90aa3af2025-11-04WarningsExact identifier
application number: M016
MedlineZINC OXIDE, PETROLATUMMedline Industries, LPf162b1a8-65b3-13a8-e053-2a95a90a3f132025-11-04WarningsExact identifier
application number: M016
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELPremier Brands of America Inc.38583c02-497b-922c-e063-6294a90a49de2025-11-03WarningsExact identifier
application number: M016
The Zoeun Omega SerumCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4277da80-b55b-74af-e063-6394a90af3252025-10-31WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELMeijer Distribution Inc03f23b04-e7f7-49b7-e063-6294a90ad58a2025-10-31WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC1852246a-6a1c-49ab-e063-6294a90a90482025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b531c1-9ab0-5ff1-e063-6394a90a29752025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b650bd-18fe-8696-e063-6394a90aa9a22025-10-30WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC20b5f354-3379-3d9f-e063-6294a90ae8172025-10-30WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-003-018450900030160 mL in 1 BOTTLE (84509-003-01) 60 ml2024-07-22NoNoCurrent