NDC 57557-100-01 - Othree 50 Whitening

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57557-100
Requested NDC: 57557-100-01
Package NDCs from labels: 57557-100-01, 57557-100-02
Manufacturer: CELLAB CO., LTD.
Effective date: 2019-12-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Drug Facts	CELLAB CO., LTD.	2019-12-18	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-01-13	Drug Facts
2022-01-28	Drug Facts
2020-03-25	Drug Facts
2020-01-31	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ACAI	INACTIVE INGREDIENT	46AM2VJ0AW	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)	INACTIVE INGREDIENT	9E4CO0W6C5	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
LAVANDULA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	19AH1RAF4M	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
SORBITAN DIOLEATE	INACTIVE INGREDIENT	6T6N9I9VD0	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
SORBITAN ISOSTEARATE	INACTIVE INGREDIENT	01S2G2C1E4	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	OTHREE 50 WHITENING (TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTOCRYLENE) CREAM [CELLAB CO., LTD.]	2

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 5 of 379 · 7,565 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Homosalate, Octisalate, Zinc oxide	HOMOSALATE, OCTISALATE, ZINC OXIDE	Aldi Inc	59cbfb14-d9b1-ce93-e063-6394a90ac312	2026-08-24	Warnings, Adverse reactions	Exact identifier unii: SOI2LOH54Z
Sterile Water	WATER	REMEDYREPACK INC.	5dd5d148-6e23-41de-bff5-551b2aea9598	2026-08-24	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	59cf1d1e-e951-9d58-e063-6394a90af0f3	2026-08-24	Warnings	Exact identifier unii: SOI2LOH54Z
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: SOI2LOH54Z unii: 15FIX9V2JP
ISNTREE HYALURONIC ACID WATERY SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	59ac747a-f9c7-2c18-e063-6394a90a2306	2026-08-23	Warnings	Exact identifier unii: 5A68WGF6WM
Claravie	ZINC OXIDE, DIMETHICONE	Gentell LLC	598a5c0b-1e2f-1335-e063-6394a90ac4f4	2026-08-21	Warnings	Exact identifier unii: SOI2LOH54Z
Sunski Sol Power Daily Face Sunscreen SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Stewart Charley Ventures, LLC	b6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c	2026-08-21	Warnings	Exact identifier unii: 5A68WGF6WM
HAWAIIAN TROPIC	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	5990fe66-4fa2-06aa-e063-6294a90a5261	2026-08-21	Warnings	Exact identifier unii: 5A68WGF6WM
Hawaiian Tropic	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	5991466a-e729-16b7-e063-6394a90a11ff	2026-08-21	Warnings	Exact identifier unii: 5A68WGF6WM
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier unii: SOI2LOH54Z
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier unii: SOI2LOH54Z
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: SOI2LOH54Z unii: 15FIX9V2JP
Sunscreen	BROAD SPECTRUM SPF 30	Concierge Choice LLC	5980055b-493e-4763-e063-6294a90a570f	2026-08-20	Warnings	Exact identifier unii: 5A68WGF6WM
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier unii: SOI2LOH54Z
Lip Balm SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Skin Script, LLC	20c5fde7-ee8f-4b74-e063-6394a90a93ec	2026-08-19	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier unii: SOI2LOH54Z
Aloe UP .5OZ SPF 50 MINERAL Sunscreen	ZINC OXIDE 14.69%	Aloe Care International, LLC	6ad80af3-78cd-4211-a5f2-68531aae264a	2026-08-19	Warnings	Exact identifier unii: SOI2LOH54Z
Utu Broad Spectrum SPF 50 Tinted Sunscreen-Stick	ZINC OXIDE	Utu Co	596e17d3-3064-1cda-e063-6294a90af963	2026-08-19	Warnings	Exact identifier unii: SOI2LOH54Z
Mineral sunscreen	MINERAL SUNSCREEN	Guangzhou Origin Beauty Cosmetics Co., Ltd.	59713657-a7ef-1aee-e063-6394a90a326e	2026-08-19	Warnings	Exact identifier unii: SOI2LOH54Z
The Naked Bee SPF 50 Mineral Sunscreen	ZINC OXIDE 14.69%	The Naked Bee	f820a9be-c94d-4fd5-b202-2dda5746a82a	2026-08-18	Warnings	Exact identifier unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.