Lip Protection

Product NDC: 85339-212
11-digit product format: 853390212
Labeler code: 85339
Product ID: 85339-212_45b3a9bc-1124-4545-e063-6394a90a5a58
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: Teton Dermatology Holdings, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-27
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: 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
3509eea7-f966-2080-e063-6294a90aeeb5	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
85339-212-45	Lip Protection	1 in 1 CARTON	STICK	1		2
85339-212-45	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
85339-212	LIP PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) STICK [TETON DERMATOLOGY HOLDINGS, INC.]	1	Current NDC, 2 package rows	20250515_3509eea7-f966-2080-e063-6294a90aeeb5.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 1 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HERA SILKYSTAY FOUNDATION 37W1	TITANIUM DIOXIDE	Amorepacific Corporation	5f4105f3-d08b-edb5-e063-6394a90ad28b	2026-11-01	Warnings	Exact identifier application number: M020
Note Mattifying Extreme Wear Foundation 130 Cool Rose	OCTINOXATE	ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI	c52d92d9-e228-4840-aacc-ed97a6173443	2026-10-29	Warnings	Exact identifier application number: M020
HERA SILKYSTAY FOUNDATION 28O1	TITANIUM DIOXIDE	Amorepacific Corporation	5ec77f7a-4621-ac0c-e063-6294a90a3f70	2026-10-26	Warnings	Exact identifier application number: M020
RoC Barrier Renew AM Moisturizer SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RoC Skincare	020aa79f-4fd6-1ea1-e063-6394a90a4464	2026-10-14	Warnings	Exact identifier application number: M020
Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15	AVOBENZONE, OCTOCRYLENE	Merle Norman Cosmetics, Inc	d5c97cdc-7f98-1a4f-e053-2995a90a089b	2026-10-12	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f8756bf-5b0d-5269-e063-6294a90ae6dc	2026-10-02	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	52bbc6cd-4bc2-7859-e063-6394a90ac87d	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	SPF50	Grace And Fire USA Inc.	2735ab0f-5eec-04c5-e063-6394a90aa60e	2026-10-01	Warnings	Exact identifier application number: M020
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled	SPF50	Grace And Fire USA Inc.	274a0544-6c71-4d91-e063-6394a90a2247	2026-10-01	Warnings	Exact identifier application number: M020
TRILIPIDERM All-Body Moisture Retention SPF-30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	Trilipid Research Institute, LLC	7f34de0a-eeb3-4b71-9abd-53d03266d993	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	6a43173f-41f9-4207-a0db-53bc8db6f4a4	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	d69b4992-d7e6-4bd7-b144-0485e35818a6	2026-09-10	Warnings	Exact identifier application number: M020
Hydra Finish SPF 15	HOMOSALATE, OCTINOXATE	Guinot	4047e8ec-834a-41e6-a144-5649a7718de4	2026-09-10	Warnings	Exact identifier application number: M020
HYDRA BEAUTE SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	806d1e18-a3fc-43df-a52a-a640902d0887	2026-09-10	Warnings	Exact identifier application number: M020
Pur Confort SPF 15	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	2fe0656f-f924-48da-91bf-d6f3d98e8fd9	2026-09-10	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	51f3d6ca-3189-4380-9afb-4259ba878274	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Creme Solaire Visage et corps SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Guinot	b0a95379-998a-4cda-bae7-63faf3d6f3c8	2026-09-10	Warnings	Exact identifier application number: M020
Sun Logic Lait Solaire Corps SPF 20	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Guinot	d9d2cee0-9189-42d0-b1ab-78b97141b128	2026-09-10	Warnings	Exact identifier application number: M020
Sunscreen	BROAD SPECTRUM SPF 30	1226 W AESTHETICS	5b0ef395-a7dd-378e-e063-6394a90a5dce	2026-09-09	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	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
85339-212-45	85339021245	1 CYLINDER in 1 CARTON (85339-212-45) / 4.5 g in 1 CYLINDER	1 cylinder	2023-10-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lip Protection	Teton Dermatology Holdings, Inc. \| Custom Analytics \| Fragrance Manufacturing INC \| Fallien Cosmeceuticals Ltd.	2025-12-11	HUMAN OTC DRUG LABEL	2