Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

Product NDC: 80971-102
11-digit product format: 809710102
Labeler code: 80971
Product ID: 80971-102_440aeb9e-256f-4e8a-e063-6394a90a9391
Type: HUMAN OTC DRUG
Nonproprietary name: TITANIUM DIOXIDE, ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Norwex Usa, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 28.8; 68 mg/mL; mg/mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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: Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	28.8 mg/mL
ZINC OXIDE	68 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
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
f527a8c5-b05e-5f3c-e053-2995a90aa1a3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80971-102-01	2023-08-09	C162847	48780-1	0191ceaa-66ad-198a-e063-dbdaa90aec3e	Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30
80971-102-01	2023-07-28	C162847	48780-1	0191ceaa-66ad-198a-e063-dbdaa90aec3e	Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80971-102-01	Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	50 mL in 1 TUBE	CREAM	50		7
80971-102-01	Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	1 in 1 CARTON	CREAM	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80971-102	PROTECT PREVENT DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [NORWEX USA, INC.]	6	Current NDC, 2 package rows	20250101_f527a8c5-b05e-5f3c-e053-2995a90aa1a3.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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium Shade	SPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADE	Autumn Harp	fd6807e1-c8c0-b361-e053-6294a90aea0c	2023-06-05	Warnings	Exact identifier application number: M020
Thinksport Clear Zinc SPF 50	ZINC OXIDE	thinkOperations,LLC	b5ce523f-eee8-f1a8-da19-b3dc14f8a58e	2023-05-31	Warnings	Exact identifier application number: M020
Thinksport Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	77b63c0b-353b-4f5f-95c7-6f7eeab81471	2023-05-30	Warnings	Exact identifier application number: M020
Think Kids Mineral SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	thinkOperations,LLC	25c59820-a08d-4abe-87ae-a787ac8b2ac2	2023-05-30	Warnings	Exact identifier application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50	ZINC OXIDE	Topiderm, Inc.	46c6f20f-4bb6-47c6-9eac-17ca97bb14a7	2023-03-20	Warnings	Exact identifier application number: M020
Replenix Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	9223ffa8-7af3-4407-9170-482afec536d8	2023-02-24	Warnings	Exact identifier application number: M020
Bath and Body Works SPF20 Coconut Lip Balm	SPF20 LIP BALM	Autumn Harp	f5744a48-2b39-4949-e053-2a95a90ab15d	2023-02-24	Warnings	Exact identifier application number: M020
Replenix Tinted Sunscreen SPF 50	ZINC OXIDE AND OCTINOXATE	Topiderm, Inc.	1fda4a54-e323-4f3c-b659-bded4b1b3dd0	2023-02-22	Warnings	Exact identifier application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e91	2023-02-22	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	3a637542-0f79-47ae-815d-84d0036c737a	2023-02-13	Warnings	Exact identifier application number: M020
Essential Moisturizing Sunscreen	ZINC OXIDE, OCTINOXATE	Topiderm, Inc.	450d916e-4c77-489e-86b1-78b686355476	2023-02-09	Warnings	Exact identifier application number: M020
Mineral Repair SPF 45	ZINC OXIDE	Topiderm, Inc.	84580f10-3119-4253-87a6-53d24a1f2227	2023-02-07	Warnings	Exact identifier application number: M020
Think Aloe and Tea Leaves Zinc oxide	ZINC OXIDE	thinkOperations,LLC	9965ccd1-821d-4d9d-8a56-e87440b809ee	2023-02-02	Warnings	Exact identifier application number: M020
Replenix Lip Therapy homosalate	HOMOSALATE	Topiderm, Inc.	b60dc004-d713-47bc-a6e9-ea4783aa7019	2023-02-02	Warnings	Exact identifier application number: M020
Josie Maran Argan Daily Moisturizer SPF47	ZINC OXIDE, TITANIUM DIOXIDE	Autumn Harp, Inc.	027821e6-db7d-4c03-956a-00313488ebc7	2023-01-14	Boxed warning, Warnings	Exact identifier application number: M020
Tinted Lip Balm SPF30 Wild Peony	SPF30 LIP BALM	Autumn Harp	d0604720-623a-e8a9-e053-2995a90ab0e6	2023-01-10	Warnings	Exact identifier application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a39d91c-2dcf-71d6-e063-6394a90a5474	2022-02-10	Warnings	Exact identifier application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3a63d3-c7e0-bf03-e063-6394a90a1662	2022-02-10	Warnings	Exact identifier application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3c0aa0-7501-7ef0-e063-6294a90a9f94	2022-02-10	Warnings	Exact identifier application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35	OCTINOXATE AND OXYBENZONE	Groupe Marcelle Inc.	c24ac3ad-b2e2-4381-bd80-a499da0e0670	2021-12-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
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
80971-102-01	80971010201	1 TUBE in 1 CARTON (80971-102-01) / 50 mL in 1 TUBE	1 tube	2023-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	Norwex Usa, Inc. \| COSMAX USA. CORPORATION	2025-11-20	HUMAN OTC DRUG LABEL	7