Powder

Product NDC: 61354-118
11-digit product format: 613540118
Labeler code: 61354
Product ID: 61354-118_348c5e36-13f6-cc86-e063-6394a90a8de8
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide
Dosage form: POWDER
Route: TOPICAL
Labeler: Oxygen Development LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-27
Substance: FERRIC OXIDE RED; TITANIUM DIOXIDE
Active strength: 1.75; 10 mg/100mg; mg/100mg
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Powder
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	1.75 mg/100mg
TITANIUM DIOXIDE	10 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
08b7eeeb-09ae-ffe6-e063-6294a90aba90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61354-118-01	Powder	100 mg in 1 CUP	POWDER	100		2
61354-118-02	Powder	1 in 1 CARTON	POWDER	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61354-118	POWDER (TITANIUM DIOXIDE) POWDER [OXYGEN DEVELOPMENT LLC]	2	Current NDC, 2 package rows	20250508_08b7eeeb-09ae-ffe6-e063-6294a90aba90.zip

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 241 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	LG H&H Co., Ltd.	0166d193-fc4d-51f7-e063-6294a90aaf32	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e831a1-c82f-3e1f-e053-2a95a90ae1f6	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e82b4e-ce84-0ca2-e053-2a95a90a88de	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	016798a8-4275-47d0-e063-6294a90a5aca	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	LG H&H Co., Ltd.	f1166cb4-b471-7043-e053-2a95a90a7fa7	2025-01-01	Warnings	Exact identifier application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	f8361aa8-c3ad-0c47-e053-6394a90a6ab0	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6807577-56a1-a40c-e053-2995a90a5935	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co.,Ltd.	0289088d-3316-c90c-e063-6294a90a69e0	2025-01-01	Warnings	Exact identifier application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	a4364c8d-8b74-130e-e053-2995a90ad1c1	2025-01-01	Warnings	Exact identifier application number: M020
b.tan Tropic Like Its Hot SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marque of Brands Americas, LLC	bb15b1bc-cfc0-0bab-e053-2a95a90af5b3	2025-01-01	Warnings	Exact identifier application number: M020
Obagi Medical Physical Defense Broad Spectrum Mineral Sunscreen SPF 50 by SUZANOBAGIMD	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	ff95a7b7-3cb4-41b0-866d-69361354a0bc	2025-01-01	Warnings	Exact identifier application number: M020
Obagi 360 HydraFactor Moisturizing Broad Spectrum SPF 30 SUNSCREEN	AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE	Obagi Cosmeceuticals LLC	84f0f1dd-13f2-49f5-89b3-fab175ac2564	2025-01-01	Warnings	Exact identifier application number: M020
NU-DERM HEALTHY SKIN PROTECTION SPF 35	OCTINOXATE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	cfb6a918-1403-4cf2-86d8-d66dd764bb6c	2025-01-01	Warnings	Exact identifier application number: M020
CLARINS Super Restorative Day Illuminating lifting replenishing BROAD SPECTRUM - SPF 20 - Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Laboratoires Clarins	c6dffe5c-5539-4e86-bf5e-b0e497eb9c88	2024-12-31	Warnings	Exact identifier application number: M020
Badger Adventure Sport Clear Mineral Sunscreen SPF 50	ZINC OXIDE	W.S. Badger Company, Inc.	d10290b4-3c8a-e0bb-e053-2995a90a9b6b	2024-12-31	Warnings	Exact identifier application number: M020
Badger BROAD SPECTRUM SPF 15 Lip Balm	ZINC OXIDE	W.S. Badger Company, Inc.	d506ac39-5019-1291-e053-2995a90a796a	2024-12-31	Warnings	Exact identifier application number: M020
Badger Kids Mineral Sunscreen Cream Broad Spectrum SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d619d2b4-bae8-bc76-e053-2995a90a369b	2024-12-31	Warnings	Exact identifier application number: M020
Badger SPF 35 Kids Clear Face Stick	ZINC OXIDE	W.S. Badger Company, Inc.	d1038442-ec86-07e3-e053-2995a90ad6ab	2024-12-31	Warnings	Exact identifier application number: M020
Badger Baby Sunscreen Cream Broad Spectrum SPF 40	ZINC OXIDE	W.S. Badger Company, Inc.	d61acaa0-73ef-eccf-e053-2995a90ad940	2024-12-31	Warnings	Exact identifier application number: M020
Badger Broad Spectrum SPF 35 Active Face Stick	ZINC OXIDE	W.S. Badger Company, Inc.	d61b0dc8-3864-d5e3-e053-2a95a90ac02f	2024-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61354-118-01	61354011801	100 mg in 1 CUP	100 mg				Historical
61354-118-02	61354011802	1 CUP in 1 CARTON (61354-118-02) / 100 mg in 1 CUP (61354-118-01)	1 cup	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PUR 4-in-1 Pressed Mineral Makeup - PORCELAIN	Oxygen Development LLC \| Oxygen Development DR Limited	2025-05-07	HUMAN OTC DRUG LABEL	2