FDA.reportPublic FDA data

EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream

Product NDC
84981-003
11-digit product format
849810003
Labeler code
84981
Product ID
84981-003_2d65b2d0-7014-d0ad-e063-6394a90ad4c2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide 20%
Dosage form
LOTION
Route
TOPICAL
Labeler
EMMA LEWISHAM US, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
ZINC OXIDE
Active strength
20 g/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
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d65b2d0-7013-d0ad-e063-6394a90ad4c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84981-003-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream100 mL in 1 JARLOTION1001
84981-003-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream1 in 1 CARTONLOTION11
84981-003-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream1 in 1 CARTONLOTION11
84981-003-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Body Cream100 mL in 1 JARLOTION1001

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 135 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db5721-2b32-d4d8-e063-6294a90a47d72025-12-11Exact identifier
application number: M020
SUNerchi Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESYNERCHI MED SPA, INC.37db14e1-f995-b649-e063-6294a90afd692025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.351ce033-6bd0-574e-e063-6394a90af4482025-12-11Exact identifier
application number: M020
208ZINC OXIDEPETER L. KOPELSON, M.D.,351c9727-d7ac-9c3f-e063-6294a90a77212025-12-11Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEMY FAVORITE PLACE SPA LLC351c0c1e-5712-1e23-e063-6394a90abe6f2025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351d27e3-00d4-8d31-e063-6394a90aaf722025-12-11Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESaving Face Skinspa Inc.351db99e-262f-b67e-e063-6394a90a34182025-12-11Exact identifier
application number: M020
Replenishing Daily Protection NTZINC OXIDEMY FAVORITE PLACE SPA LLC351c5f6f-86e6-7219-e063-6294a90a37452025-12-11Exact identifier
application number: M020
Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDAISY'S SKIN TRANSFORMATION LLC37d9fbf5-d602-d3dc-e063-6394a90abe532025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d53a7-be0b-4d7a-e063-6394a90a37c42025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d9c77-ed9f-a518-e063-6394a90a34fa2025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374e2294-7281-c7b9-e063-6394a90acc892025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
application number: M020
Non - Tinted Mineral SunscreenZINC OXIDENEXTEX CORPORATION35bacfcf-0254-aa0a-e063-6394a90a14752025-12-11Exact identifier
application number: M020
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
application number: M020
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
application number: M020
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
application number: M020
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84981-003-01849810003011 JAR in 1 CARTON (84981-003-01) / 100 mL in 1 JAR1 jar2025-06-01NoNoCurrent
84981-003-02849810003021 JAR in 1 CARTON (84981-003-02) / 100 mL in 1 JAR1 jar2025-06-01NoNoCurrent