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 27 of 375 · 7,499 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Odacite Color Balm - Frosted Petal	ZINC OXIDE	Odacite	52ba9423-8b9d-38f7-e063-6394a90a95da	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - Dawn	ZINC OXIDE	Iris and Romeo	52bb700b-ff56-2286-e063-6394a90ac458	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - Camellia	ZINC OXIDE	Iris and Romeo	52bb52ec-2cd7-f8cc-e063-6294a90aa61b	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bubble Solar Mate Daily Mineral Sunscreen SPF 40	ZINC OXIDE	Bubble Beauty, Inc.	d2eca90f-9463-4d2f-975d-02f2802ded3e	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Plexus Sun Shield Hydrating Mineral Sunscreen SPF 30	ZINC OXIDE	Plexus Worldwide, LLC	55c391fa-37c6-47a2-befd-12888eb5fc18	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - Suede	ZINC OXIDE	Iris and Romeo	52bb7505-a027-2533-e063-6294a90a2520	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	LOreal USA Products Inc	9c909ae0-0117-4675-afc2-533d542f3659	2026-05-26	Warnings	Exact identifier unii: 5A68WGF6WM
Iris and Romeo Weekend Skin Moisture Lip Balm - Carob	ZINC OXIDE	Iris and Romeo	52bbe9da-37f8-b3ba-e063-6394a90a139e	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - Cameo	ZINC OXIDE	Iris and Romeo	52bc0174-872d-445b-e063-6294a90ab329	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Iris and Romeo Weekend Skin Moisture Lip Balm - Iconic	ZINC OXIDE	Iris and Romeo	52bbfdfe-dfc9-364f-e063-6294a90a646d	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulip Dew Bronze	ZINC OXIDE	Bloomeffects	52bc7f23-3594-3173-e063-6294a90a81ea	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulip Dew	ZINC OXIDE	Bloomeffects	0fcb1b45-c04d-310a-e063-6294a90ab56d	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulipscreen Hydrating Lip Oil Mauve Moment	ZINC OXIDE	Bloomeffects	52bd7522-81b5-6189-e063-6394a90a29b4	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulipscreen Hydrating Lip Oil Barely	ZINC OXIDE	Bloomeffects	52bd8a43-a8c2-897e-e063-6394a90a9f3d	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulipscreen Hydrating Lip Oil Fruit Punch	ZINC OXIDE	Bloomeffects	52bdc0ec-ac5e-4a57-e063-6294a90a0b3b	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Bloomeffects Tulipscreen Hydrating Lip Oil Tulipy Pink	ZINC OXIDE	Bloomeffects	52bdc5cc-9742-4af6-e063-6294a90aba22	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Alleyoop Sun Serum Lip Oil - Daylight	ZINC OXIDE	NewAlley Innovations Inc	52be1071-67cb-f2c0-e063-6294a90a368c	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Alleyoop Sun Serum Lip Oil - Hazy	ZINC OXIDE	NewAlley Innovations Inc	52be3c9e-a791-5053-e063-6294a90a1b30	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
Alleyoop Sun Serum Lip Oil - Whirlwind	ZINC OXIDE	NewAlley Innovations Inc	52be633a-fc64-7456-e063-6294a90a8fc0	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z
DRMTLGY Lip Silk - Bold	ZINC OXIDE	DRMTLGY	52be6cdf-9ee5-6ce5-e063-6294a90a6075	2026-05-26	Warnings	Exact identifier unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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