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 180 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Ivory	ZINC OXIDE	Cosmetic Enterprises Ltd	2748c351-0a7d-6913-e063-6394a90a6ef2	2025-10-13	Warnings	Exact identifier application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 Nude	ZINC OXIDE	Cosmetic Enterprises Ltd	265bd73f-2509-90c6-e063-6294a90a2e19	2025-10-13	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	dad4b244-2d34-40cb-88dc-991358df83b0	2025-10-10	Warnings	Exact identifier application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	eafc00ce-12e7-921f-e053-2995a90a241a	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	50adf1db-118f-4843-b356-e23993160673	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	e0949325-7de1-4da4-82b6-8004916412a0	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d0294b-e937-336d-e063-6294a90a5c3c	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free Sunscreen	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	9adea1a4-efa6-4fe1-85e8-ed69fa098a87	2025-10-10	Warnings	Exact identifier application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Wilc Healthcare Inc	60e7ed8e-f421-4e08-97a8-af647200e4ae	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30	ZINC OXIDE	Wilc Healthcare Inc	e5820376-897f-4c77-aadc-7991137870b7	2025-10-10	Warnings	Exact identifier application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45	ZINC OXIDE	Wilc Healthcare Inc	247a323f-9a08-4717-8553-ebc9c519817b	2025-10-10	Warnings	Exact identifier application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38	TITANIUM DIOXIDE	Eai-jr 286, Inc	b6c316c3-661b-6428-e053-2a95a90a1a6b	2025-10-10	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	40d15366-85b8-f5e8-e063-6294a90a5fd8	2025-10-10	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4369f2f-fdc3-e48e-e053-2995a90a07f7	2025-10-10	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50	AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE	Wasatch Product Development, LLC	f4ac746a-a50a-8041-e053-2a95a90a8ea6	2025-10-10	Warnings	Exact identifier application number: M020
Wonderscreen Broad Spectrum SPF 30	ZINC OXIDE	Wasatch Product Development, LLC.	e895d942-e50e-1ad6-e053-2995a90a0e02	2025-10-10	Warnings	Exact identifier application number: M020
Illuminating SPF 50 plus drops Broad Spectrum Sunscreen	ZINC OXIDE	Cosmetic Enterprise Ltd	13f40485-b98e-e804-e063-6394a90af2af	2025-10-10	Warnings	Exact identifier application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Cosmetic Enterprises LTD	a84d246b-1153-85ff-e053-2995a90a270a	2025-10-10	Warnings	Exact identifier application number: M020
MediChoice Moisturizing Lip Balm SPF15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	O&M HALYARD, INC.	00327815-28f0-4198-bca7-c8ae768ff416	2025-10-09	Warnings	Exact identifier application number: M020
Daybird 4-in-1 Skin Tint Serum	ZINC OXIDE	Resette, Inc.	19c1a934-b0f5-1068-e063-6294a90a3b1f	2025-10-09	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