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 289 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	WALGREEN COMPANY	f9c81d88-8e28-fa53-e053-6394a90ac5c4	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa18067a-310b-bdc3-e053-6394a90aee79	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	24223fbf-8ce9-ec5e-e063-6294a90a29da	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	2422b327-ea83-f4c3-e063-6394a90a5c6e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Watermelon Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24256e54-ae34-91b2-e063-6394a90a33c0	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Premium Face Moisturizing Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24265a48-fd07-c78a-e063-6394a90ab67e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2410df0a-db52-0769-e063-6394a90a52f3	2024-10-09	Warnings	Exact identifier application number: M020
Walgreens Broad Spectrum SPF 40 Radiant Facial Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24114416-33b9-c6ba-e063-6394a90a6f3b	2024-10-09	Warnings	Exact identifier application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	0c40a46b-b9f9-8e14-e063-6394a90a9573	2024-10-09	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	531f60c9-c89a-46bc-8460-d01b2e838e6f	2024-10-08	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	AMOREPACIFIC CORPORATION	60964d9f-d96c-4397-b273-6b63d1886722	2024-10-08	Warnings	Exact identifier application number: M020
IOPE AIR CUSHION Cover 21 Vanilla	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	29d6cc8d-1469-479d-a15a-e78d4e22d4a2	2024-10-08	Warnings	Exact identifier application number: M020
IOPE UV DEFENSE SUN PROTECTOR	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0f2a87f7-2185-16a5-e063-6294a90a92a3	2024-10-08	Warnings	Exact identifier application number: M020
Tropical Topical Matte SPF30	ZINC OXIDE	Allure Labs	039fba4b-720a-9199-e063-6394a90adbfb	2024-10-08	Warnings	Exact identifier application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0e746836-ed84-7b33-e063-6294a90aeff3	2024-10-08	Warnings	Exact identifier application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	PureTek Corporation	86eb06cc-d63f-4500-a52e-14ef99a56532	2024-10-02	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a	2024-10-01	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen	ZINC OXIDE	Fallien Cosmeceuticals, LTD	231af290-99ee-e94d-e063-6394a90a0bef	2024-09-27	Warnings	Exact identifier application number: M020
Target Up and Up SPF 70 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	23085ab9-5abb-a572-e063-6394a90ae34a	2024-09-26	Warnings	Exact identifier application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and Ceramides	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	TARGET CORPORATION	23598ad1-12a3-fe65-e063-6394a90a4f6f	2024-09-26	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