TIBENA EVERY DAY REAL SUN BLOCK

Product NDC: 74740-450
11-digit product format: 747400450
Labeler code: 74740
Product ID: 74740-450_4bbb94e5-ada3-ab07-e063-6394a90a1b01
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: KONAD CO LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-09
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 9.6 g/50mL; 1.56 g/50mL
Listing certified through: 2027-12-31
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: TIBENA EVERY DAY REAL SUN BLOCK
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	9.6 g/50mL
TITANIUM DIOXIDE	1.56 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
211c9930-4f91-cf8f-e063-6394a90a97b3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d676a241-be05-4740-b3ee-1a5f2ed422d2	Product name	4	20180615
dd8bd48f-20d6-43c7-b471-3ae872868afa	Product name	3	20180125
d41954ff-bc63-4b2c-aba0-9146707659d7	Product name	2	20151117

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
74740-450-01	TIBENA EVERY DAY REAL SUN BLOCK	50 mL in 1 TUBE	CREAM	50		2
74740-450-02	TIBENA EVERY DAY REAL SUN BLOCK	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
74740-450	TIBENA EVERY DAY REAL SUN BLOCK (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KONAD CO LTD]	1	2 package rows	20240924_211c9930-4f91-cf8f-e063-6394a90a97b3.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 95 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eucerin Oil-Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cda04484-ba84-2276-e053-2a95a90a41c8	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	240dd76a-8f39-caec-e063-6294a90abbbc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan SPF 30	AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3994886-2ebe-a9d2-e053-2995a90aaf9a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3d471b8-7430-98b0-e053-2995a90aba4b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	241f78be-0d7f-c5ca-e063-6294a90a997a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Protect and Tan Sunscreen SPF 45	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdort Inc	d39a009d-1f33-88bb-e053-2a95a90a03a0	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	d460d669-42df-46c0-e053-2a95a90ad77b	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 8	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d370094c-3373-594b-e053-2a95a90a114a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	0a5a35be-9e24-18dd-e063-6394a90a097f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d462081f-f082-5df2-e053-2995a90aa1d9	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d3e66496-bc3c-d189-e053-2a95a90a06b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc.	c05388dc-4282-ee79-e053-2a95a90a376a	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Glow Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	b60dcbd1-42d0-646f-e053-2a95a90a497d	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Complete Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	d474fea9-65a7-672b-e053-2a95a90ab989	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 40	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	d4d9ad73-6394-2391-e053-2a95a90a2df6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	df498e82-e1c9-51eb-e053-2a95a90a49b6	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Tanning Sunscreen SPF 15	AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%	Beiersdorf Inc	d3984138-763b-1002-e053-2995a90acefc	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	d8b0d5ad-a82c-5304-e053-2a95a90afa63	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	d8d80a15-8282-a18e-e053-2a95a90a2c6c	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Waterbabies Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%	Beiersdorf Inc	d915cb28-2813-5a38-e053-2a95a90a45c6	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
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	Status
74740-450-01	74740045001	50 mL in 1 TUBE	50 ml			Historical
74740-450-02	74740045002	1 TUBE in 1 BOX (74740-450-02) / 50 mL in 1 TUBE (74740-450-01)	1 tube	2024-09-09	0	Current