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 108 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Avail Facial Sunscreen SPF 25	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Emeis Cosmetics Pty Ltd	7be903e4-5f07-35b2-e053-2991aa0a1340	2025-12-17	Warnings	Exact identifier application number: M020
Mineral Sheer Stick	ZINC OXIDE	Supergoop, LLC	0beed72e-51df-d15a-e063-6394a90af559	2025-12-17	Warnings	Exact identifier application number: M020
Sunscreen Lotion118ml	ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%	Foshan Sugar Max Cosmetics CO.,Ltd	4620c41a-2188-00f5-e063-6394a90a613c	2025-12-17	Warnings	Exact identifier application number: M020
Sunscreen Cream	ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46224dbe-a0fb-c242-e063-6394a90a2634	2025-12-17	Warnings	Exact identifier application number: M020
CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N	ENSULIZOLE, OCTISALATE	Parfums Christian Dior	31141a45-54e2-4463-ab42-4df56d911650	2025-12-17	Warnings	Exact identifier application number: M020
Perricone High Potency Face Finishing and Firming Moisturizer	TITANIUM DIOXIDE, ZINC OXIDE	THG Beauty USA LLC	2409cea1-7077-dc12-e063-6294a90a4558	2025-12-17	Warnings	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	3635a073-5484-f96c-e063-6394a90adef5	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Lip	TITANIUM DIOXIDE, ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	36362dc7-31d7-f766-e063-6294a90a129b	2025-12-17		Exact identifier application number: M020
Mineral Sunscreen Non-Tinted	ZINC OXIDE	Glow Advanced Skin and Body Care, LLC	3635e45b-6978-ac69-e063-6294a90a22ac	2025-12-17		Exact identifier application number: M020
Prime and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Shannon Cornelsen-Lewandowski	36480f7f-37e8-decd-e063-6394a90ada60	2025-12-17		Exact identifier application number: M020
Prime and Protect	TITANIUM DIOXIDE, ZINC OXIDE	Shannon Cornelsen-Lewandowski	364827bd-5781-eb53-e063-6394a90ab22f	2025-12-17		Exact identifier application number: M020
non-tinted face mineral sunscreen SPF40	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	3649bf1a-17c3-fe0b-e063-6294a90a13c0	2025-12-17		Exact identifier application number: M020
Tinted Mattifying Face Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	3649f634-8bcd-b3c1-e063-6394a90a49d9	2025-12-17		Exact identifier application number: M020
tinted face and body mineral sunscreen SPF40	ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364a1edd-56e1-55f0-e063-6294a90a45a6	2025-12-17		Exact identifier application number: M020
non-tinted face and body mineral sunscreen SPF40	ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364a8c8d-df84-e568-e063-6394a90aaff1	2025-12-17		Exact identifier application number: M020
tinted lip mineral sunscreen SPF45	TITANIUM DIOXIDE, ZINC OXIDE	Lisa Nadler Skin Care and Waxing	364b023b-4a52-225a-e063-6394a90ad197	2025-12-17		Exact identifier application number: M020
ULTAMATTE PROTECTION SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	SKINFINITY	37efc466-17b8-9f7b-e063-6294a90a8c88	2025-12-17		Exact identifier application number: M020
ULTRA SILK PROTECTION SUNSCREEN	ZINC OXIDE	SKINFINITY	383ea760-d55e-a32a-e063-6294a90aa3d2	2025-12-17		Exact identifier application number: M020
Bella Blu Skin Care Non Tinted Sunscreen	ZINC OXIDE	BELLA BLU STUDIOS INC	3f67134c-88e8-8513-e063-6294a90aaf5a	2025-12-17	Warnings	Exact identifier application number: M020
Bella Blu Skin Care Non Tinted Sunscreen	ZINC OXIDE	BELLA BLU STUDIOS INC	3f66d2ae-00e7-608c-e063-6294a90a49c6	2025-12-17	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