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 2 of 379 · 7,565 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	e8730127-2d8d-4b80-ab90-d2f136d9e516	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger	LIP BALM SUNSCREEN	Jack Black, LLC	d961d22a-2125-41e9-94a3-5b53d12b320f	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Intense Lip Therapy SPF25, Black Tea and Blackberry	LIP BALM SUNSCREEN	Jack Black, LLC	172a70bc-8a09-4258-b9bf-cf3c67ff7613	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Asian Pear	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	acace707-6671-4818-86f2-d9813792157a	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Basil Lemon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	277cb44d-608a-4ffc-a2a5-ac57d33d214c	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Black Cherry	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8f413bd6-258c-4c3c-89d1-369938c85720	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Cucumber Lime	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	5f15bee9-9bf4-4f27-a6b5-4205deb625f6	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Winter Melon	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	e7792b4e-a6d2-487e-ba28-27b68e6d7e27	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Intense Therapy Lip Balm Vanilla Bourbon	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	517040d1-e6ed-40ca-a46f-2f75403dbc3c	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Intense Therapy Lip Balm Mango and Mandarin	SUNSCREEN SKIN PROTECTANT LIP BALM	Jack Black, LLC	8c55d1cd-cdd6-468b-8a17-b940c6210116	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Intensive Therapy Lip Balm Mango Chili Lime	AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN	Jack Black, LLC	51349d57-b14d-4798-8d68-03fbe3713d1e	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Sun Guard Sunscreen SPF45	SUNSCREEN	Jack Black, LLC	3cc86bb2-05ce-47eb-8c71-f4f116ca5840	2026-09-08	Warnings	Exact identifier unii: SOI2LOH54Z unii: 4Y5P7MUD51
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea Butter	LIP BALM SUNSCREEN	Jack Black, LLC	518cb17a-fdaa-4a60-93fc-708305366eb8	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
Jack Black Lavender Lip Balm 0.25oz	LIP BALM SUNSCREEN	Jack Black, L.L.C.	e8c6a6d9-1093-41f1-87d5-faf8583d4319	2026-09-08	Warnings	Exact identifier unii: 4Y5P7MUD51
SPF15 lip balm 01	OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	f8695305-b89d-c21c-e053-6394a90a0e84	2026-09-08	Warnings	Exact identifier unii: 5A68WGF6WM
Sunscreen stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f963ee-a98c-efc1-e053-2a95a90aaf53	2026-09-08	Warnings	Exact identifier unii: 5A68WGF6WM
SPF30 Sunscreen 01	AVOBENZONE ,HOMOSALATE,OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5b04751d-32e9-a7e2-e063-6294a90aefbd	2026-09-08	Warnings	Exact identifier unii: 5A68WGF6WM
Juyasuyon Invisible Sunscreen	HOMOSALATE,OCTOCRYLENE,OCTISALATE,BEMOTRIZINOL,AVOBENZONE	Guangdong Aimu Biological Technology Co., Ltd	5ab335b5-bb9e-4642-e063-6294a90a3986	2026-09-05	Warnings	Exact identifier unii: 5A68WGF6WM
No7 Future Renew Defense Shield SPF 50	AVOBENZONE, OCTINOXATE, OCTISALATE	BCMC	41cc2c52-c6a4-611c-e063-6294a90aae01	2026-09-03	Warnings	Exact identifier unii: 4Y5P7MUD51
WALMART EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALMART, INC.	58b5d0ce-9157-9dee-e063-6394a90ab543	2026-09-02	Warnings	Exact identifier unii: 5A68WGF6WM

Reported adverse events (FAERS/openFDA)#

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