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 3 of 379 · 7,565 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chantecaille Ultra Sun Protection Sunscreen SPF 45	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Chantecaille Beaute Inc	6186ea56-7d56-43f5-985d-a012f1296afa	2026-09-02	Warnings	Exact identifier unii: 5A68WGF6WM unii: 4Y5P7MUD51
Sun Wave Anti Aging Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	2d5fa597-08a8-41ca-ba9e-b52e41a5c70c	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sunski Hot Block Mineral Sunscreen Stick SPF 50	ZINC OXIDE	Stewart Charley Ventures LLC dba Sunski	04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a8	2026-09-01	Warnings	Exact identifier unii: SOI2LOH54Z
Sun Wave Anti Aging Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7e48a3d2-e453-4733-b42b-8bea804cda59	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Anti Aging Lite SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7204c24f-aab6-45eb-9bd4-879f715ba075	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Anti Aging Lite SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	7c1e780a-1831-4f49-a92e-e36017d241a2	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	d45614c8-b09c-417b-b691-082ea2149880	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	999b0b17-be73-4d42-b182-ce038f493301	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Cross Sport Insta Dry SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	adffff46-4cfb-4c0a-b1a6-75220ee193a5	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Cross Sport Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	13b2b45b-70e1-46ff-8555-48e1fe98c651	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sun Wave Kids Insta Dry SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Life Brands, LLC	5c2a5ca3-e9eb-48ba-8698-592d2c7aa241	2026-09-01	Warnings	Exact identifier unii: 5A68WGF6WM
Sunceutical SPF 50 Mineral Face Cream	ZINC OXIDE	Baxter Laboratories Pty. Ltd.	2c408728-a1de-d51e-e063-6294a90ade0b	2026-08-31	Warnings	Exact identifier unii: SOI2LOH54Z
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UV	BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE	Craver Corporation	38d8c1c9-86b5-1edd-e063-6394a90aeb47	2026-08-30	Warnings	Exact identifier unii: 5A68WGF6WM
ISNTREE HYALURONIC ACID NATURAL SUNCREAM	ZINC OXIDE	ISNTREE Inc.	5a3a59b2-18b6-521b-e063-6294a90a2958	2026-08-29	Warnings	Exact identifier unii: SOI2LOH54Z
Cetaphil Daily Facial Moisturizer with suncreen SPF 35	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	f5eb347f-0d46-4de6-8f3f-9010327678ed	2026-08-28	Warnings	Exact identifier unii: 5A68WGF6WM
Calamine	FERRIC OXIDE RED	Your Military Exchanges	af95a66c-f063-4019-80c6-6f7dc4fee4d8	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: SOI2LOH54Z
Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen	ZINC OXIDE	Utu Co	59938ace-c97c-d758-e063-6394a90a77e4	2026-08-28	Warnings	Exact identifier unii: SOI2LOH54Z
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen Unscented	ZINC OXIDE	Utu Co	5982e790-7cdb-c96c-e063-6394a90a02d4	2026-08-28	Warnings	Exact identifier unii: SOI2LOH54Z
Utu Hydrating Sun Balm Broad Spectrum SPF 50	ZINC OXIDE	Utu Co	59d1d0ac-2444-d6f9-e063-6294a90ae80c	2026-08-28	Warnings	Exact identifier unii: SOI2LOH54Z
Hello Bello Mineral Sunscreen SPF 50	ZINC OXIDE	Topiderm, Inc.	54f12764-5c37-4a05-bf96-209fedb93fd1	2026-08-28	Warnings	Exact identifier unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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