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
Ingredient	Strength
ZINC OXIDE	20 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c703df8-23af-d630-e063-6294a90a1a24	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84981-005-01	EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	50 mL in 1 JAR	LOTION	50	1
84981-005-01	EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	1 in 1 CARTON	LOTION	1	1
84981-005-02	EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	1 in 1 CARTON	LOTION	1	1
84981-005-02	EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	50 mL in 1 JAR	LOTION	50	1

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 240 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6dcdb08-3407-90e1-e053-2a95a90a83bf	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6de8135-3c70-2036-e053-2995a90a040b	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6deadbd-524f-7506-e053-2a95a90a0a1b	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	fmg Co.Ltd	02e61a43-3021-edc1-e063-6294a90ad4b6	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	02e64868-d545-4af7-e063-6394a90aa7c7	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	fmg Co.Ltd	f114e45c-6c31-2382-e053-2995a90ac754	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9c-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9e-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	f8377d02-6c58-c240-e053-6294a90a44c0	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d67faeb3-0b73-5b6e-e053-2a95a90aac2b	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	02e63ed6-1f49-45c0-e063-6394a90a58bf	2025-01-01	Warnings	Exact identifier application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d2fadd51-6bd8-ae70-e053-2995a90a6213	2025-01-01	Warnings	Exact identifier application number: M020
Jergens Natural Glow Face Moisturizer Medium to Deep Skin Tones	AVOBENZONE,OCTISALATE, OCTOCRYLENE	Kao USA Inc.	ff601f5c-b8ed-ee21-e053-6294a90aadba	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d309eebc-44f4-bce6-e053-2995a90a3bd2	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a3bcb-5113-0a85-e053-2995a90a3937	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30a9f96-f99b-4610-e053-2995a90a3f91	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a7ecc-ea54-d1b9-e053-2995a90a7017	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a87b9-90f9-35b2-e053-2995a90aea2c	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30ab7a5-d38c-ba62-e053-2995a90a57fd	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e82b4e-ce83-0ca2-e053-2a95a90a88de	2025-01-01	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84981-005-01	84981000501	1 JAR in 1 CARTON (84981-005-01) / 50 mL in 1 JAR	1 jar	2025-06-01	No	No	Current
84981-005-02	84981000502	1 JAR in 1 CARTON (84981-005-02) / 50 mL in 1 JAR	1 jar	2025-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face Cream	EMMA LEWISHAM US, INC. \| Baxter Laboratories Pty. Ltd.	2025-02-05	HUMAN OTC DRUG LABEL	1