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: 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: Mineral Lip Protection
Listing expiration: 2027-12-31

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 259 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Medicated Lip Balm Original	DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1	2024-12-17	Warnings	Exact identifier application number: M020
Mentholatum Natural Ice Sport SPF 30	AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATE	The Mentholatum Company	57c35631-42d3-4c6c-bcbb-e2de92b45b13	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	5f09503e-c455-4ac2-8d07-e8e66c2daa32	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to Medium	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	b5ca4bed-4f89-4020-a055-9d11f4cd5058	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	e5fffd20-1d22-485a-9311-4cb4f9264f6f	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	404990e4-9499-4186-b39d-afc31834d334	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to Deep	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	6028e210-a8a3-4d84-a462-16a414c31052	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very Light	HOMOSALATE, OCTINOXATE, OXYBENZONE	Mary Kay Inc.	af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e8	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30	AVOBENZONE/OCTISALATE/OCTOCRYLENE	Mary Kay Inc.	00f0f30d-236a-fd45-e063-6294a90a747d	2024-12-17	Warnings	Exact identifier application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted Berry	DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE	The Mentholatum Company	bab8447b-58b8-4160-a91e-05f9fd09ed1d	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE	MAKEUP ART COSMETICS	fb59afc1-1dc9-f783-e053-6394a90a196b	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30	ZINC OXIDE	Mary Kay Inc.	0e9b15e4-e59c-f266-e063-6394a90ab81c	2024-12-17	Warnings	Exact identifier application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREEN	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	MAKEUP ART COSMETICS	e5fd3e40-de1d-4cdd-b725-4a517514ca35	2024-12-17	Warnings	Exact identifier application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	2d034810-7210-4ad4-be23-ec2100f8c2f1	2024-12-17	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	acda1640-0d35-43dc-8734-d47b00cc85ed	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay Foundation Primer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Mary Kay Inc.	59d25b44-1adb-4790-8ce6-2d847a06b8b3	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm The Go Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	cf7fb8f0-483d-443b-b381-086a255f0783	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Sampler Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	0a9ee359-19c1-4266-8a51-a68f655de151	2024-12-17	Warnings	Exact identifier application number: M020
Mary Kay TimeWise Repair Volu-Firm Set	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	Mary Kay Inc.	d459e2f7-dc78-4519-9733-01495fc447a2	2024-12-17	Warnings	Exact identifier application number: M020
Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50	ZINC OXIDE	Babo Botanicals, Inc.	2982ce67-f136-b93b-e063-6394a90a81ac	2024-12-17	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