Mineral Lip Protection

Product NDC: 85563-212
11-digit product format: 855630212
Labeler code: 85563
Product ID: 85563-212_46041f25-f600-ee00-e063-6394a90aaa56
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: CLEAR SKIN SOLUTIONS, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-11
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 55; 40 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Mineral Lip Protection
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	55 mg/g
TITANIUM DIOXIDE	40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
35bd148c-43c7-aa93-e063-6394a90abc8b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85563-212-45	Mineral Lip Protection	4.5 g in 1 CYLINDER	STICK	4.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
85563-212	MINERAL LIP PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) STICK [CLEAR SKIN SOLUTIONS, LLC]	1	Current NDC, 1 package rows	20250523_35bd148c-43c7-aa93-e063-6394a90abc8b.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 225 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF50 SHEER GLOW BALM CHAMPAGNE 9g	ZINC OXIDE 22.75%	NAKED SUNDAY PTY LTD	fbfb871b-460f-271a-e053-6394a90acad2	2025-03-22	Warnings	Exact identifier application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g	ZINC OXIDE	NAKED SUNDAYS PTY LTD	2f42d22a-983e-d304-e063-6294a90a3719	2025-03-22	Warnings	Exact identifier application number: M020
SPF50 SHEER GLOW BALM ROSE 9g	ZINC OXIDE 22.75%	NAKED SUNDAY PTY LTD	fbfbd0dd-8961-5fd0-e053-6294a90a5de4	2025-03-22	Warnings	Exact identifier application number: M020
Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19g	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8%	NAKED SUNDAYS PTY LTD	2f47a6c9-dd0a-da94-e063-6294a90a9a45	2025-03-22	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Firming Protocol	TITANIUM DIOXIDE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	67ba9f32-bbf4-4c14-9e97-08f1cb7d3996	2025-03-21	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Brightening Protocol	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	2f75ebf7-d6b6-45c6-ad5b-61739d260ff7	2025-03-21	Warnings	Exact identifier application number: M020
Hello Kitty Fun Broad Spectrum SPF 40	ZINC OXIDE	The Creme Shop Inc	30d37581-122c-ec92-e063-6294a90ab425	2025-03-21	Warnings	Exact identifier application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40	ZINC OXIDE	The Creme Shop Inc	30d3ed8c-f424-8d95-e063-6394a90a0cbc	2025-03-21	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	c7142781-fa57-43e5-9436-cb29dd03a669	2025-03-21	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	30de3d87-6cc7-b779-e063-6294a90a72f4	2025-03-21	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	00ec7d9c-8550-45ce-8d0a-ef2caf84f98d	2025-03-21	Warnings	Exact identifier application number: M020
Obagi Skintrinsiq Clarifiying Protocol	SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	08ba9ea8-73fd-472b-9cc4-67df167352ec	2025-03-21	Warnings	Exact identifier application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	3e51da46-6a81-4b74-b16e-3fc298a4ba59	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	2d2c58e2-0d15-4383-adae-12fc17b8ea50	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	1907126c-fd95-86e8-e063-6394a90a23ca	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	4504a10d-6130-4ec5-823a-ab970709e6d7	2025-03-20	Warnings	Exact identifier application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Eai-jr 286, Inc	30caf1dd-142d-85d3-e063-6394a90a0c88	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	d8ad45dc-e0ec-4324-b93e-8cf405d1d471	2025-03-20	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
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
85563-212-45	85563021245	4.5 g in 1 CYLINDER (85563-212-45)	4.5 g	2019-07-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mineral Lip Protection	CLEAR SKIN SOLUTIONS, LLC \| Custom Analytics LLC \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-15	HUMAN OTC DRUG LABEL	2