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 196 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GR LONGSTAY Matte Face Powder SPF 15	OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	62759398-4935-4732-b950-cfbeab82bc5a	2025-08-07	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	3bac8d0a-8726-46c3-e063-6294a90a1075	2025-08-06	Warnings	Exact identifier application number: M020
Tanning Club Golden Glow Tanning Oil SPF 15	AVOBENZONE, OCTISALATE, OCTOCRYLENE	TANNING CLUB, LLC	33478e28-b079-4e52-9924-845d127be286	2025-08-06	Warnings	Exact identifier application number: M020
Tanning Club Everyday Sunscreen SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	TANNING CLUB, LLC	805048c4-f2b3-4d35-8674-f44cf3d1a4b5	2025-08-06	Warnings	Exact identifier application number: M020
PoolBar I Scream For Sunscreen SPF 50 Coconut and Vanilla	AVOBENZONE, OCTISALATE, OCTOCRYLENE	POOLBAR	deddb91d-b2d5-4d97-bc38-5c11abde9d43	2025-08-06	Warnings	Exact identifier application number: M020
PoolBar I Scream For Sunscreen SPF 30 Coconut and Vanilla	AVOBENZONE, OCTISALATE, OCTOCRYLENE	POOLBAR	7f16b91d-29e4-4c21-a008-5dcc858c83d8	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 17W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	053cb3cd-dd16-4d08-b347-a4349fa37c07	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7bf90657-b636-41d6-b96c-88d174989f5b	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	da7e19cd-6a8b-47df-bfc9-2f0f11b7955c	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f7a1d379-6de0-4be4-84a9-e0ebef332bef	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 18N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	671be8a6-51b7-45d2-9fff-c7736d2eea3e	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 19W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9efa5db5-d774-4089-895c-9667eda0f11b	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 20C Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	76232666-e23f-4842-bd0d-37819739ec3a	2025-08-06	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 21W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	876b9a5d-dae3-47f1-9da6-b5e179fd28cd	2025-08-06	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 50 Zinc Oxide Continuous Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3bba29ab-0e08-b751-e063-6294a90adb7b	2025-08-06	Warnings	Exact identifier application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3bba70e9-da29-f43b-e063-6294a90a08ef	2025-08-06	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50	TITANIUM OXIDE, ZINC OXIDE	NAKED SUNDAYS PTY LTD	0127f290-8c5e-4285-e063-6294a90ae128	2025-08-06	Warnings	Exact identifier application number: M020
GR HD FOUNDATION HIGH DEFINITION SPF 15	AVOBENZONE, OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	e36550a6-a231-41a8-abda-afdbb2449eaa	2025-08-06	Warnings	Exact identifier application number: M020
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream Palette	OCTINOXATE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	cca417c8-b882-48a7-8bd8-ccc6f961a3d2	2025-08-06	Warnings	Exact identifier application number: M020
GR SATIN SMOOTHING Fluid Foundation SPF 15	OCTINOXATE, OXYBENZONE	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	1eba51f2-782e-480e-8555-f5ad8883fa0d	2025-08-06	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