SHEER MINERAL SUNSCREEN

Product NDC: 84009-816
11-digit product format: 840090816
Labeler code: 84009
Product ID: 84009-816_59a8d775-c366-4056-a985-e80f47f4bfe3
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Plant Devas Inc. dba evanhealy
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-01
Substance: ZINC OXIDE
Active strength: 20 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: SHEER MINERAL SUNSCREEN
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
f620ef44-f30c-4cc9-bc82-28dc4a47a8da	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84009-816-01	SHEER MINERAL SUNSCREEN	1 in 1 BOX	CREAM	1	2
84009-816-01	SHEER MINERAL SUNSCREEN	60 mL in 1 TUBE	CREAM	60	2
84009-816-02	SHEER MINERAL SUNSCREEN	30 mL in 1 BOTTLE, GLASS	CREAM	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84009-816	SHEER MINERAL SUNSCREEN (ZINC OXIDE) CREAM [PLANT DEVAS INC. DBA EVANHEALY]	2	Current NDC, 3 package rows	20250406_f620ef44-f30c-4cc9-bc82-28dc4a47a8da.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 147 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Replenishing Daily Protection Sunscreen Invisible	ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32462e88-0e74-a675-e063-6294a90ac564	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32465271-abb9-d03f-e063-6294a90a990e	2025-12-08		Exact identifier application number: M020
Mineral Based Foam Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	32486bfb-0cc8-0283-e063-6394a90a9967	2025-12-08		Exact identifier application number: M020
Harrys Daily Facial SPF Broad Spectrum	ZINC OXIDE	Harry's, Inc.	39fdde34-45ec-bc22-e063-6394a90a7dce	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Brightening plus Tint	ZINC OXIDE	ZEN DERMATOLOGY, INC.	31e32e9c-9e0b-b678-e063-6294a90a66f5	2025-12-08		Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine plus Tint	ZINC OXIDE	Zen Dermatology, Inc.	31576340-cb11-d944-e063-6294a90adef2	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen No Shine - No Tint	TITANIUM DIOXIDE, ZINC OXIDE	Zen Dermatology, Inc.	31572a16-5f60-565f-e063-6394a90ab8c9	2025-12-08	Warnings	Exact identifier application number: M020
Healthy Mineral Sunscreen Face and Body	ZINC OXIDE	Zen Dermatology, Inc.	31e376b4-098f-34d7-e063-6394a90a1772	2025-12-08		Exact identifier application number: M020
AcneFix Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	315894b7-ac1b-0982-e063-6294a90ab879	2025-12-08		Exact identifier application number: M020
Shunly Natural Cover SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Shunly Skin Care	a64e373b-b3f6-4024-b5f5-253783485cd6	2025-12-08	Warnings	Exact identifier application number: M020
AcneFix Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ACNEFIX INC.	31583c7e-365a-d899-e063-6394a90aa63f	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334ec844-5560-50f7-e063-6394a90a01be	2025-12-08		Exact identifier application number: M020
Mineral Fusion Tinted	TITANIUM DIOXIDE, ZINC OXIDE	FOREFRONT DERMATOLOGY, S.C.	334f90d6-68e5-db37-e063-6294a90a5fb1	2025-12-08		Exact identifier application number: M020
Skin Apeel Pure Protect SPF 40 Broad Spectrum	ZINC OXIDE	Skin Apeel, Inc.	18e78c7f-1523-a4f4-e063-6394a90aed97	2025-12-08	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c44baf4-9555-faad-e063-6294a90ab24f	2025-12-08	Warnings	Exact identifier application number: M020
Glow Stick	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c54b857-c017-a953-e063-6394a90a38df	2025-12-08	Warnings	Exact identifier application number: M020
Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c545e55-3f55-842b-e063-6394a90ae48e	2025-12-08	Warnings	Exact identifier application number: M020
Bare Barrier Sport	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c580794-eda3-de57-e063-6294a90a0303	2025-12-08	Warnings	Exact identifier application number: M020
Flawless Brightening Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Flawless Skin Care LLC	312e9ca0-a388-a546-e063-6294a90a15d6	2025-12-08	Warnings	Exact identifier application number: M020
Mineral SPF 40, protect	TITANIUM DIOXIDE, ZINC OXIDE	Acne Specialists LLC	2f8859cf-8277-6ea9-e063-6294a90a1a75	2025-12-08	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
84009-816-01	84009081601	1 TUBE in 1 BOX (84009-816-01) / 60 mL in 1 TUBE	1 tube	2024-03-01	No	No	Current
84009-816-02	84009081602	30 mL in 1 BOTTLE, GLASS (84009-816-02)	30 ml	2025-04-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SHEER MINERAL SUNSCREEN	Plant Devas Inc. dba evanhealy \| Sun Deep Inc.	2025-04-02	HUMAN OTC DRUG LABEL	2