Mineral Creme SPF 50

Product NDC: 49358-570
11-digit product format: 493580570
Labeler code: 49358
Product ID: 49358-570_36d85f1d-3e7b-cf54-e063-6394a90af1ba
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 20; 170 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49358-570-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49358-570-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49358-570-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49358-570-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49358-570-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49358-570-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49358-570-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49358-570-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49358-570-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49358-570-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49358-570-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49358-570-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49358-570-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49358-570-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Mineral Creme SPF 50
Brand name suffix: Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	20 mg/mL
ZINC OXIDE	170 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
f8e178d6-058c-462a-8e59-6721f28ad040	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49358-570-01	2025-06-05	Mineral Crème SPF 50 Mineral Crème SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)
49358-570-02	2025-06-05	Mineral Crème SPF 50 Mineral Crème SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)
49358-570-01	2025-01-30	Mineral Crème SPF 50 Mineral Crème SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)
49358-570-02	2025-01-30	Mineral Crème SPF 50 Mineral Crème SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49358-570-01	Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	50 mL in 1 TUBE	CREAM	50	2
49358-570-01	Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	1 in 1 CARTON	CREAM	1	2
49358-570-02	Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	100 mL in 1 TUBE	CREAM	100	2
49358-570-02	Mineral Creme SPF 50Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-570	MINERAL CREME SPF 50 MINERAL CREME SPF 50 BROAD SPECTRUM UVA-UVB SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]	1	Current NDC, 4 package rows	20230910_f8e178d6-058c-462a-8e59-6721f28ad040.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 91 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bellas Friends Sunscreen Stick	ZINC OXIDE	Panergytek Usa Inc	478cbdeb-28e4-fa56-e063-6294a90af124	2026-01-04	Warnings	Exact identifier application number: M020
Bellas Friends Roll-on Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	PANERGYTEK USA INC	478d46ce-14e8-2231-e063-6394a90a3e27	2026-01-04	Warnings	Exact identifier application number: M020
Ava Isa Sun Lip Sun Whip Clear Sunshine	ZINC OXIDE	Cyberderm Laboratories inc.	a8646ee4-5e6e-6cdd-e053-2a95a90aee77	2026-01-01	Warnings	Exact identifier application number: M020
Ava Isa Sun Lip Sun Whip Strawberry Zinnia	ZINC OXIDE	Cyberderm Laboratories inc.	a888396f-489f-7e7c-e053-2995a90aee5b	2026-01-01	Warnings	Exact identifier application number: M020
Ava Isa Sun Lip Sun Whip Watermelon Lily	ZINC OXIDE	Cyberderm Laboratories inc.	a8889754-8e33-4d2a-e053-2995a90a6080	2026-01-01	Warnings	Exact identifier application number: M020
OKeeffes Lip Repair	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE	The Gorilla Glue Company/O'Keeffe's Company	6805b3e9-77cb-bfee-e053-2991aa0a8d98	2026-01-01	Warnings	Exact identifier application number: M020
Walgreens 50 Pina Colada Scented Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	4978c811-be34-9fc3-e063-6394a90a2d80	2026-01-01	Warnings	Exact identifier application number: M020
Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Jailbreak Toys, Inc. DBA UNICORN SNOT	498b7c1a-e66d-9736-e063-6394a90a4712	2026-01-01	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Ltd	f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0	2026-01-01	Warnings	Exact identifier application number: M020
MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5	ZINC OXIDE	Formula 7venz L.L.C.	5f3cdec9-2cc2-4660-827f-d286883d907c	2025-12-31	Warnings	Exact identifier application number: M020
SOLARA SUNCARE - GO VACATION GLOW SPF 30	ZINC OXIDE	SOLARA SUNCARE, INC.	1f5cb694-f065-7ebc-e063-6394a90a883a	2025-12-31	Warnings	Exact identifier application number: M020
SUNSCREEN GLOWING, SPF 30	SUNSCREEN GLOWING LOTION	FSA Store Inc	473bcb90-ab7f-170b-e063-6294a90a99d5	2025-12-31	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	05ba5966-f0ff-5360-e063-6294a90a0fc9	2025-12-31	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	08f4599b-de62-2bc7-e063-6394a90a69ab	2025-12-31	Warnings	Exact identifier application number: M020
Hawaiian Tropic Everyday Active SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc8e2ee8-e67f-ef5d-e053-2995a90a1520	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Glowing, SPF 30	SUNSCREEN GLOWING LOTION	Cardinal Health, Inc	28ed3b60-1139-f657-e063-6394a90a52fa	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	Cardinal Health, inc.	293e9656-8644-b9aa-e063-6294a90a5b27	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	FSA Store Inc	473d6804-8d20-6899-e063-6294a90a3131	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47428cd4-fbad-ba7a-e063-6394a90a1c5c	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47433a62-91e0-b031-e063-6294a90a0d49	2025-12-31	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
49358-570-01	49358057001	1 TUBE in 1 CARTON (49358-570-01) / 50 mL in 1 TUBE	1 tube	2023-07-01	No	No	Current
49358-570-02	49358057002	1 TUBE in 1 CARTON (49358-570-02) / 100 mL in 1 TUBE	1 tube	2023-07-01	No	No	Current