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 139 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UV Defense me. Matte Airy-Fit Sunscreen	ZINC OXIDE	MAGNIF CO., LTD	459f2b8d-453c-4dee-e063-6394a90a4509	2025-12-10	Warnings	Exact identifier application number: M020
RoC Hydration Plus SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	45a3e250-8195-344d-e063-6294a90ae681	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	bf3c1474-e353-63a5-e053-2a95a90a9b26	2025-12-10	Warnings	Exact identifier application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Roc Skincare	f161d754-0c32-2fbe-e053-2a95a90a6b47	2025-12-10	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242ff053-b8c0-4f90-e063-6294a90a7bb3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247ef1f8-ad12-4f80-e063-6394a90a3e3c	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e810d366-0c32-5b1c-e053-2a95a90a622e	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242b7d0e-82d8-793c-e063-6294a90a4aa3	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	eb744367-f318-e1e2-e053-2a95a90a2cc4	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	242faaed-e85a-a1d7-e063-6294a90aea92	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247d6c0e-8f88-faf0-e063-6394a90a10da	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Aekyung Industrial Co., Ltd.	1e9a5c77-7027-3b52-e063-6394a90ac0eb	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	e8241828-17b2-96c5-e053-2a95a90a12e5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	1176181b-1331-ba68-e063-6394a90a961a	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247b56ad-4b61-8b6f-e063-6394a90af3b6	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	247afcae-855e-3f69-e063-6394a90a4231	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	24306304-4d0d-c5f0-e063-6394a90afad5	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Aekyung Industrial Co., Ltd.	1f9c7718-6fde-236c-e063-6394a90afa19	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3482855b-de85-a5a7-e063-6294a90a55ae	2025-12-09	Warnings	Exact identifier application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3483e7e6-b301-136d-e063-6294a90aba18	2025-12-09	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