FDA.reportPublic FDA data

EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream

Product NDC
84981-005
11-digit product format
849810005
Labeler code
84981
Product ID
84981-005_2c703df8-23b0-d630-e063-6294a90a1a24
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 Face 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
2c703df8-23af-d630-e063-6294a90a1a24Available 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
84981-005-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream50 mL in 1 JARLOTION501
84981-005-01EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONLOTION11
84981-005-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream1 in 1 CARTONLOTION11
84981-005-02EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream50 mL in 1 JARLOTION501

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 146 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safe Sea SPF sport 65HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD0ed3242b-ac35-4d98-a777-1e44bb32a4672025-12-08WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD46641a33-d658-4ef0-9b7a-062adc401dde2025-12-08WarningsExact identifier
application number: M020
Skin Filter Glow SPFZINC OXIDEMALORIE MILES36485f44-a6bd-9529-e063-6294a90af7a42025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3647f983-9e75-8955-e063-6294a90af1622025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES36499be5-d680-92bf-e063-6394a90a89db2025-12-08Exact identifier
application number: M020
Skin Filter Matte SPFTITANIUM DIOXIDE, ZINC OXIDEMALORIE MILES3649f758-e31b-3c6a-e063-6294a90a5c362025-12-08Exact identifier
application number: M020
Body-ScreenZINC OXIDEMALORIE MILES364ae392-480a-14ea-e063-6394a90a38832025-12-08Exact identifier
application number: M020
Personalized Moisturizer SPF 30ZINC OXIDE 10.00%Proven Skincared3cf8f81-d6ae-4570-ad86-43415e973e132025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2f9d087c-b2b3-5654-e063-6294a90a94e52025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faee7ef-fc0c-6d01-e063-6294a90a6d682025-12-08WarningsExact identifier
application number: M020
GLOW SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2faf530d-5574-b702-e063-6294a90ad6fd2025-12-08WarningsExact identifier
application number: M020
MATTE SHIELD SPFZINC OXIDEACNE SOLUTIONS NYC INC2fb00db0-4c37-56c6-e063-6294a90a8aff2025-12-08WarningsExact identifier
application number: M020
Matte Shield SPFTITANIUM DIOXIDE, ZINC OXIDEACNE SOLUTIONS NYC INC3bb582ec-71e7-4ad8-e063-6394a90a94d42025-12-08WarningsExact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334afdc8-1e12-d787-e063-6294a90aed7c2025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334bf8ea-2485-84e8-e063-6294a90aefa62025-12-08Exact identifier
application number: M020
SPF 101 Lightly TintedZINC OXIDEThe Acne Lab LLC334d694a-f9e4-ae86-e063-6394a90abfe12025-12-08Exact identifier
application number: M020
SPF 101 Non-TintedZINC OXIDEThe Acne Lab LLC334e32a4-c3a5-e37d-e063-6294a90ad6cf2025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245561d-a90c-7bf0-e063-6394a90ab3b62025-12-08Exact identifier
application number: M020
Mineral Based Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3245c1f7-2c1b-b6ad-e063-6394a90aaee62025-12-08Exact identifier
application number: M020
Mineral Based Facial SunscreenZINC OXIDEKATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION3e8981ed-5847-7009-e063-6394a90a49a12025-12-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84981-005-01849810005011 JAR in 1 CARTON (84981-005-01) / 50 mL in 1 JAR1 jar2025-06-01NoNoCurrent
84981-005-02849810005021 JAR in 1 CARTON (84981-005-02) / 50 mL in 1 JAR1 jar2025-06-01NoNoCurrent