Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50

Product NDC: 53208-800
11-digit product format: 532080800
Labeler code: 53208
Product ID: 53208-800_2c6c3748-418a-33ac-e063-6294a90adbca
Type: HUMAN OTC DRUG
Nonproprietary name: Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: LG H&H Co., Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-27
Substance: TITANIUM DIOXIDE; ENSULIZOLE; OCTINOXATE; ZINC OXIDE; OCTISALATE
Active strength: 2.285; 1.75; 3.5; 5.825; 2.25 g/50mL; 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	53208-800-01	`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	53208-800-01	`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: Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	2.285 g/50mL
ENSULIZOLE	1.75 g/50mL
OCTINOXATE	3.5 g/50mL
ZINC OXIDE	5.825 g/50mL
OCTISALATE	2.25 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
9YQ9DI1W42	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4X49Y0596W	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
a4364c8d-8b74-130e-e053-2995a90ad1c1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75	Product name	2	20250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53208-800-01	Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	2 in 1 BOX	LOTION	2		3
53208-800-01	Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	50 mL in 1 TUBE	LOTION	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53208-800	BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 (ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [LG H&H CO., LTD.]	3	Current NDC, Legacy NDC, 2 package rows	20250125_a4364c8d-8b74-130e-e053-2995a90ad1c1.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 31 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SunPlus Healthy Skin Sunny Living SPF 30 Mist Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	9b168046-3536-4ba9-9b5f-4f8c50b8b354	2026-05-14	Warnings	Exact identifier application number: M020
SunPlus Healthy Skin Sunny Living SPF 50 Mist Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SUNPLUS SKIN CARE LLC	0e60ecee-d9f4-47e0-92f7-ff319e4422dd	2026-05-14	Warnings	Exact identifier application number: M020
Hampton Sun SPF 15 Sunscreen	OCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%	S&C Hampton Sun LLC	3ce75e74-b5d3-4fbe-8d44-9b6f14f354df	2026-05-14	Warnings	Exact identifier application number: M020
Target Up and Up SPF 30 Deep Repair Facial Moisturizer Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	51c9bdee-dcff-2818-e063-6294a90abb47	2026-05-14	Warnings	Exact identifier application number: M020
Hampton Sun SPF 50 Baby Mineral	ZINC OXIDE 20%	S&C Hampton Sun LLC	42037d8c-4787-4e16-93fe-0d19b6b888fd	2026-05-14	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	29c9d1cb-e249-47fa-a46d-42190e59d352	2026-05-14	Warnings	Exact identifier application number: M020
Hampton SPF 15 UV-Advanced Sunscreen	HOMOSALATE 7.50% OCTISALATE 5.00% AVOBENZONE 3.00%	S&C Hampton Sun LLC	1659a681-6cf8-45ba-b1f8-e330eee3b9d4	2026-05-14	Warnings	Exact identifier application number: M020
Easy Everything Sunscreen	ZINC OXIDE	VLT Ventures LLC	51cd48cf-38ae-f347-e063-6294a90a8a90	2026-05-14	Warnings	Exact identifier application number: M020
Hampton Sun SPF 4	OCTOCRYLENE 4.00% AVOBENZONE 2.00%	S&C Hampton Sun LLC	68763abc-0d6b-441c-9a99-cf3dc86e6deb	2026-05-14	Warnings	Exact identifier application number: M020
Easy Everything Sunscreen	ZINC OXIDE	VLT Ventures LLC	51cdbac3-7f44-d72d-e063-6294a90a2f99	2026-05-14	Warnings	Exact identifier application number: M020
Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift Set	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4feb1010-469f-7e6e-e063-6394a90a9a9e	2026-05-14	Warnings	Exact identifier application number: M020
Round Lab Summer Travel Kit	AVOBENZONE, HOMOSALATE, OCTISALATE	SEORIN COMPANY Co., Ltd.	4f8722e2-4636-e8ba-e063-6294a90a91e4	2026-05-14	Warnings	Exact identifier application number: M020
La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	f3d841aa-b4fe-4a9d-8ad2-edd4445852d2	2026-05-14	Warnings	Exact identifier application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle	AVOBENZONE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	b746c24d-f775-4433-8519-49c3ec48ea0c	2026-05-14	Warnings	Exact identifier application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50	DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE	LOreal USA Products Inc	92a1d6ce-aff3-45fc-8d98-20c4375aded8	2026-05-14	Warnings	Exact identifier application number: M020
MELAO TALLOW SUNSCREEN	ETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATE	Guangzhou Haishi Biological Technology Co., Ltd.	519d9f52-b704-d6cd-e063-6294a90a6e42	2026-05-13	Warnings	Exact identifier application number: M020
Hampton Sun SPF30 Mineral	ZINX OXIDE	S&C Hampton Sun LLC	019b0c1a-f9f3-4756-8b24-35bf4dc4aa22	2026-05-13	Warnings	Exact identifier application number: M020
Standard Procedure SPF 50 Sunscreen Face and Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories	34f6150d-9627-94a5-e063-6394a90ad448	2026-05-13	Warnings	Exact identifier application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	defa9588-95be-4f5c-86bb-53d6a1df7f5f	2026-05-13	Warnings	Exact identifier application number: M020
MELAO TALLOW SUNSCREEN	ETHYLHEXYL METHOXYCINNAMATE	Guangzhou Haishi Biological Technology Co., Ltd.	22982b28-37df-ed81-e063-6394a90a77db	2026-05-12	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
9YQ9DI1W42	ENSULIZOLE	27503-81-7	ENSULIZOLE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53208-800-01	53208080001	2 TUBE in 1 BOX (53208-800-01) / 50 mL in 1 TUBE	2 tube	2020-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
53208-800-01 Babience KIDS Sunscreen SPF 50 pinkfong BABY SHARK 50ml	LG H&H Co., Ltd. \| fmg Co.Ltd	2025-01-01	HUMAN OTC DRUG LABEL	3