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 177 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	THG Beauty USA LLC	254b4692-a459-6119-e063-6394a90a0a60	2025-10-23	Warnings	Exact identifier application number: M020
AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENE	CHOP SAVER FRESH CITRUS SPF 15 LIP BALM	Good for the Goose Products, LLC	2786cec8-0b8e-9c83-e063-6394a90ab338	2025-10-23	Warnings	Exact identifier application number: M020
Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Naturopathica Holistic Health	41d75815-e281-bf88-e063-6294a90afeff	2025-10-23	Warnings	Exact identifier application number: M020
Thrive Daily Sunscreen For Sensitive Skin SPF 30	ZINC OXIDE	Thrive Natural Care, Inc	128e1a3a-df40-f51c-e063-6394a90a1902	2025-10-23	Warnings	Exact identifier application number: M020
Thrive Bodyshield 50 SPF 50	ZINC OXIDE	Thrive Natural Care, Inc	12d9e1d0-c59c-f770-e063-6294a90a8191	2025-10-23	Warnings	Exact identifier application number: M020
Bondi Sands Broad Spectrum SPF 60 Sunny Cream Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	2861453a-12e9-faeb-e063-6394a90a527c	2025-10-23	Warnings	Exact identifier application number: M020
Good Defense Daily Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	Offspring Beauty Co.	2a462e60-6353-f791-e063-6294a90a62e3	2025-10-23	Warnings	Exact identifier application number: M020
Skin Solution Multi-Serum Skin Tint SPF 40	ZINC OXIDE	Offspring Beauty Co.	2d598f5d-d23f-6d54-e063-6294a90a778d	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Kids	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36c7a1be-87e5-1f87-e063-6394a90ad876	2025-10-23	Warnings	Exact identifier application number: M020
Aussiezinc Mineral Sunscreen SPF50 Baby	ZINC OXIDE	Veganic SKN Limited	16cc5178-e4c7-38eb-e063-6294a90a66de	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Everyday	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36c9e96f-0299-095b-e063-6394a90a411d	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Anti-Aging - Light Tint	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36c9f293-58c8-1a6f-e063-6394a90adc1f	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium Tint	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca1103-b9bf-2573-e063-6394a90acdc5	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra Sensitive	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca5334-fd41-297f-e063-6394a90ac72e	2025-10-23	Warnings	Exact identifier application number: M020
Mineral Sun Drops	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	d8acda81-4430-42f8-be56-d28bb010e630	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c34c1486-fa6c-485f-80b3-98e397b3dddb	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	74c078ec-a371-4406-8d5e-a0baada3a1a6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2765f345-eab2-4878-b1f1-f8e243083476	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	d1181543-07ab-4a51-8b55-afc1a98293f6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c7be3a7e-f031-4ec0-b9dc-41c025cd0066	2025-10-22	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