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 267 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d8551c6-2efe-11a8-e063-6294a90aed01	2024-12-01	Warnings	Exact identifier application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d958343-31e3-0b7a-e063-6294a90a424a	2024-12-01	Warnings	Exact identifier application number: M020
Attitude Kids mineral sunscreen unscented SPF 30	ZINC OXIDE	9055-7588 Qubec Inc. DBA Attitude	c2461e22-1518-4f9e-ad8c-951784ef8b5f	2024-12-01	Warnings	Exact identifier application number: M020
BIO SPECTRA ATTITUDE	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	954713fe-c84c-41b4-913d-3507ed91e55d	2024-12-01	Warnings	Exact identifier application number: M020
CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Caudalie USA, Inc.	150e3bf3-7b05-e611-e063-6294a90a0932	2024-11-29	Warnings	Exact identifier application number: M020
CLEARING DEFENSE SPF30	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE	Dermalogica, LLC.	2cb559d3-dd79-4951-ad38-190fd4dd7c40	2024-11-27	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	1ccde0bc-08aa-8a25-e063-6394a90a2762	2024-11-25	Warnings	Exact identifier application number: M020
Girlyish Skincare Mineral Sunscreen SPF 30	ZINC OXIDE	Rise Skincare LLC	137ba0be-91ce-4bd0-9713-57b169359750	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	95d657e5-cf89-48dd-a12e-f9664b131eb9	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	33f42840-92f8-4fa1-86e9-ec0a06d637de	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	20785934-e534-4ea5-8c15-f9669b042153	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e4464601-a9ec-413b-a883-9efe61f2f5b2	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5e7c879c-1e5c-4614-bec1-d363978c3b0d	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5c1f1f09-19fb-4ceb-bb6d-22d51b5733a8	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c8a48759-efac-47ac-972a-c994b6774e20	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	793c18e5-4363-45b0-a184-0b6c69a91b2c	2024-11-25	Warnings	Exact identifier application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8a542b3c-c3c0-465a-9b24-6a62016656f3	2024-11-25	Warnings	Exact identifier application number: M020
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110C	OCTINOXATE, ZINC OXIDE	BEL STAR S A	27c30645-dcef-bc31-e063-6394a90a1368	2024-11-25	Warnings	Exact identifier application number: M020
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15	OCTINOXATE AND TITANIUM DIOXIDE	Bobbi Brown Professional Cosmetics Inc.	b669c36d-4c94-455d-8534-9c3bb024d668	2024-11-25	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands, LLC	8a1eefa6-619e-5d02-e053-2995a90a3d75	2024-11-25	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