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 234 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
natural lip balm SPF15(unflavored) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	2c5a460a-dc93-14cc-e063-6294a90a0b61	2025-01-23	Warnings	Exact identifier application number: M020
360 by QUR Lemon Verbena lip balm	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Qur, Inc	bedb14c2-9181-5970-e053-2a95a90a4161	2025-01-23	Warnings	Exact identifier application number: M020
Soleo Organics Sunscreen	ZINC OXIDE	SE Operations Pty Ltd	59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b	2025-01-22	Warnings	Exact identifier application number: M020
Neptune Ave. High Dive Barrier Repair Moisturizer Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Neptune Ave. Inc.	25034563-6420-daf6-e063-6394a90af980	2025-01-22	Warnings	Exact identifier application number: M020
Jafra Sun body protector sunscreen broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b8e49dd6-305c-f717-e053-2995a90a659c	2025-01-22	Warnings	Exact identifier application number: M020
Jafra Royal Defy Sample Kit	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	c3b265b1-ab84-4ea9-b283-c92f5a4cf461	2025-01-22	Warnings	Exact identifier application number: M020
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	2c4eaf2e-b034-8185-e063-6394a90a8275	2025-01-22	Warnings	Exact identifier application number: M020
Herbalife SKIN Protective Moisturizer Broad Spectrum SPF 30 Mineral Sunscreen	ZINC OXIDE	Herbalife International of America Inc.	d30b7cf1-73bb-3568-e053-2995a90ad579	2025-01-21	Warnings	Exact identifier application number: M020
Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Herbalife International of America, Inc.	d30d9d02-bc31-db3c-e053-2a95a90a0dab	2025-01-21	Warnings	Exact identifier application number: M020
Sugargirl Disco Stick SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	36f30834-62be-4076-9493-f385720a1e22	2025-01-20	Warnings	Exact identifier application number: M020
Sugargirl Glowy Face Screen Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE	I World LLC	757897b0-fc65-4147-8444-2a0efdc6f81c	2025-01-20	Warnings	Exact identifier application number: M020
Sugargirl Hot Body Screen Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, AVOBENZONE, OCTISALATE	I World LLC	a9bf1342-1c4b-48ad-a955-715647df125a	2025-01-20	Warnings	Exact identifier application number: M020
Sunceutical SPF 50 Mineral Glow Serum	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c2c9b67-9588-efbe-e063-6294a90aa6a4	2025-01-20	Warnings	Exact identifier application number: M020
JAFRA SKIN Glow Face Cream Broad Spectrum SPF 15 Sunscreen	HOMOSALATE, OCTISALATE, AVOBENZONE,OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V	f627ab5b-85d4-4c92-9412-4bab72828f3d	2025-01-17	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2be9f92a-a041-0595-e063-6394a90af7a8	2025-01-17	Warnings	Exact identifier application number: M020
Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50	MINERAL SUNSCREEN	The Center Brands, LLC	cd35ae20-d5b7-479d-8a5e-0278eae9e83c	2025-01-17	Warnings	Exact identifier application number: M020
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	293a6a6c-adf3-452d-92f5-3baceb619e39	2025-01-16	Warnings	Exact identifier application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	594982d5-b4bf-4889-99b7-b3cd58fa8031	2025-01-16	Warnings	Exact identifier application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	26f1dcde-209e-4c6d-9577-1f3d3e21595f	2025-01-16	Warnings	Exact identifier application number: M020
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	adba288c-e94f-4b26-8f7d-336f3e5108bd	2025-01-16	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