O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN

Product NDC: 53208-650
11-digit product format: 532080650
Labeler code: 53208
Product ID: 53208-650_2c6c0e3e-572e-0669-e063-6394a90acbc0
Type: HUMAN OTC DRUG
Nonproprietary name: Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: LG H&H Co., Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-31
Substance: OCTOCRYLENE; ZINC OXIDE; OCTISALATE; TITANIUM DIOXIDE
Active strength: 4; 8.73; 2.5; 1.53 g/50mL; g/50mL; g/50mL; g/50mL
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53208-650-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53208-650-50	`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: O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	4 g/50mL
ZINC OXIDE	8.73 g/50mL
OCTISALATE	2.5 g/50mL
TITANIUM DIOXIDE	1.53 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	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
f8361aa8-c3ad-0c47-e053-6394a90a6ab0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53208-650-50	O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	50 mL in 1 TUBE	CREAM	50		3
53208-650-50	O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	2 in 1 BOX	CREAM	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53208-650	O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN (OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LG H&H CO., LTD.]	3	Current NDC, 2 package rows	20250125_f8361aa8-c3ad-0c47-e053-6394a90a6ab0.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 115 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0400b-8ad9-654b-e063-6294a90ad040	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c00301-ee41-333c-e063-6294a90a61d5	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c078fa-05f9-ad80-e063-6394a90af3bb	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c108f6-a928-0a54-e063-6394a90ae686	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0ccca-c993-181e-e063-6294a90a7ae6	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0a55d-16d3-086a-e063-6394a90a30cf	2025-12-16		Exact identifier application number: M020
Eucerin Radiant Tone	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	2611e0cb-d56d-6ea1-e063-6294a90a745b	2025-12-16	Warnings	Exact identifier application number: M020
Really Great Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c1341d-fbf5-56a5-e063-6294a90aa045	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	KLOE SALON LLC	36c23c07-2011-3ddb-e063-6294a90a76e9	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sun Defense	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c465ea-979b-9474-e063-6394a90ab3f8	2025-12-16		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c4a27b-96e9-4f30-e063-6294a90a5655	2025-12-16		Exact identifier application number: M020
Mineral Sunscreen Non Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SAN JOSE MEDICAL SPA	37ef19e5-1775-a8d5-e063-6394a90acaef	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	BABYFACE LLC	36d69eb5-59b4-14a0-e063-6394a90a0a49	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d6141c-6967-d779-e063-6294a90af0a7	2025-12-16		Exact identifier application number: M020
Replenishing Daily Sunscreen	ZINC OXIDE	BABYFACE LLC	36d773d7-349d-68c1-e063-6394a90aff1e	2025-12-16		Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d44158a-44b3-5a3d-e063-6294a90a1f16	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light-Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d53071f-0275-d00c-e063-6294a90afcca	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d550967-25af-3e7a-e063-6394a90a2c79	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium-Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d57790c-22cf-08aa-e063-6394a90aeac0	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d5813e8-a219-db90-e063-6294a90a6ca7	2025-12-16	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53208-650-50	53208065050	2 TUBE in 1 BOX (53208-650-50) / 50 mL in 1 TUBE	2 tube	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
53208-650-50 O HUI Day Shield Perfect Sun Black Broad Spectrum SPF 50 Sunscreen	LG H&H Co., Ltd. \| fmg Co.Ltd	2025-01-01	HUMAN OTC DRUG LABEL	3