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 13 of 379 · 7,565 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norwex Lip Glaze Broad Spectrum SPF 30 Rose	ZINC OXIDE	Norwex Usa, Inc.	565feded-8e25-e628-e063-6294a90aee48	2026-07-11	Warnings	Exact identifier unii: SOI2LOH54Z
PoutScreen Lip Treatment Lemon Meringue	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	563e3ab9-4ee2-279c-e063-6294a90a7cf1	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN	ZINC OXIDE	COSMAX USA, CORPORATION	5643a73d-757c-702d-e063-6294a90a2c12	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE	ZINC OXIDE	COSMAX USA, CORPORATION	5643d655-e335-5643-e063-6394a90a483a	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
MUSELY DAYCREAM SPF40	ZINC OXIDE	COSMAX USA, CORPORATION	56443156-3edb-a643-e063-6394a90adf9f	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	Cosmax USA, Corporation	56445f2d-8e5a-34eb-e063-6294a90ae26e	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
Hello Kitty Fun Broad Spectrum SPF 40	ZINC OXIDE	Cosmax USA Corporation	5644854e-18d6-617d-e063-6294a90ab3e7	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
Hello Kitty Sunny Days Broad Spectrum SPF 40	ZINC OXIDE	Cosmax USA Corporation	5644855d-f864-e07b-e063-6394a90a5148	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40	ZINC OXIDE	COSMAX USA, CORP	5644d49f-08b9-e806-e063-6294a90a80f9	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	564682e5-1051-9936-e063-6394a90abe1d	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRM	ZINC OXIDE	COSMAX USA, CORP	5646e069-5461-12c5-e063-6294a90abacb	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
Protect Sport Sunscreen	BROAD SPECTRUM SPF 30	Opal Day Spa	564704f2-b26a-d737-e063-6294a90aa6ff	2026-07-10	Warnings	Exact identifier unii: 5A68WGF6WM
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	5647162a-610e-2789-e063-6294a90a7549	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVE	ZINC OXIDE	COSMAX USA, CORP	56472adb-572d-5a52-e063-6294a90a3cc3	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOL	ZINC OXIDE	COSMAX USA, CORP	56474782-beff-8437-e063-6294a90a8322	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACH	ZINC OXIDE	COSMAX USA, CORP	564749f3-e820-9003-e063-6294a90a0265	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL	ZINC OXIDE	COSMAX USA, CORP	56477f58-3878-81fa-e063-6294a90a87b7	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM	ZINC OXIDE	COSMAX USA, CORP	5647ae2c-bcba-63c0-e063-6394a90ad5bc	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM	ZINC OXIDE	COSMAX USA, CORP	56478f3d-f25c-bef7-e063-6294a90ade09	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL	ZINC OXIDE	COSMAX USA, CORP	564796f8-072f-61f2-e063-6394a90ab394	2026-07-10	Warnings	Exact identifier unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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