Petroleum-Free Lip Balm

Product NDC: 53329-092
11-digit product format: 533290092
Labeler code: 53329
Product ID: 53329-092_40c101e4-f9c5-4766-e063-6294a90aaa46
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate and Oxybenzone
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2010-04-01
Substance: OCTINOXATE; OXYBENZONE
Active strength: 2; 4.5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	53329-092		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53329-092	53329-092-83	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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: Petroleum-Free Lip Balm
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2 g/100g
OXYBENZONE	4.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	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
6125d98a-6fc7-4f50-924e-3b1f7ee951f4	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-08-08	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2023-07-28	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-09-27	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm
2022-07-29	092 Curad Petroleum-Free Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-092-83	Petroleum-Free Lip Balm	4.2 g in 1 CONTAINER	LIPSTICK	4.2		8
53329-092-83	Petroleum-Free Lip Balm	1 in 1 BOX	LIPSTICK	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-092	PETROLEUM-FREE LIP BALM (OCTINOXATE AND OXYBENZONE) LIPSTICK [MEDLINE INDUSTRIES, LP]	7	Current NDC, Legacy NDC, 2 package rows	20241204_6125d98a-6fc7-4f50-924e-3b1f7ee951f4.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 211 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB Suncreen	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	4c7f0257-fa12-40d6-9516-824b0e3a182c	2025-06-05	Warnings	Exact identifier application number: M020
Mineral KidCreme SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	MDSolarSciences	9ec56c68-6fea-444b-aeed-0b5d60c42e75	2025-06-05	Warnings	Exact identifier application number: M020
Kidspray Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	MDSolarSciences	36df811b-35d2-261d-e063-6394a90aa91e	2025-06-05	Warnings	Exact identifier application number: M020
5-IN-1 TINTED FACE SUNSCREEN - FAIR	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	c0892856-cd12-4c1f-8420-866dbd0f8907	2025-06-04	Warnings	Exact identifier application number: M020
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	fbf8be03-93e2-4d7e-e053-6294a90a4fd5	2025-06-04	Warnings	Exact identifier application number: M020
EltaMD UV Clear SPF46	ZINC OXIDE AND OCTINOXATE SUNSCREEN	CP Skin Health Group, Inc.	60438ec5-0b1f-45fd-8ce4-debfdbdc6721	2025-06-04	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face Sunscreen SPF 50	OCTOCRYLENE, ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b00d0efe-bf22-43a6-ba24-3d5b6ee9c5e1	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	2ea86aa8-2f28-40bb-9318-fec188f66010	2025-06-03	Warnings	Exact identifier application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50	ZINC OXIDE	LIKE PRO OPTIMAL SKINCARE LLC	b59a3b67-0e44-426d-9379-0ca31628937a	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun EthoSport Stick Broad Spectrum SPF 40	ZINC OXIDE	EthoSun, Inc	35372859-8f40-5eb0-e063-6294a90a6a00	2025-06-03	Warnings	Exact identifier application number: M020
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45	ZINC OXIDE	EthoSun, Inc	d7d2bca6-5000-4cb9-b004-b1ae286f6035	2025-06-03	Warnings	Exact identifier application number: M020
Age Defense for Eyes 5 in 1	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	48d5343a-1068-4c64-a275-c180026d6947	2025-06-03	Warnings	Exact identifier application number: M020
Ola Botanicals Sunscreen SPF 30	ZINC OXIDE	Natural Health Partners, LLC	c7a7df0b-da8f-407d-a1ee-28f75070b23c	2025-06-02	Warnings	Exact identifier application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	95ea5442-a7ca-0c7d-e053-2a95a90ad247	2025-06-02	Warnings	Exact identifier application number: M020
Bluevado Sunfix	ZINC OXIDE, TITANIUM DIOXIDE	Magic Blue, LLC	31f1e961-3719-f70a-e063-6394a90a481e	2025-05-31	Warnings	Exact identifier application number: M020
Sunny Sailor First Mate Face Stick SPF 30	ZINC OXIDE	SUNNY SAILOR LLC	8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e	2025-05-28	Warnings	Exact identifier application number: M020
Dr Mercola Broad Spectrum SPF15	ZINC OXIDE	Natural Health Partners, LLC	47f6b19e-ede8-0daf-e054-00144ff88e88	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	ZINC OXIDE	Natural Health Partners, LLC	47f6ec0a-1144-55dd-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Dr. Mercola Broad Spectrum	TITANIUM DIOXIDE, ZINC OXIDE	Natural Health Partners, LLC	47f6ab9e-fa73-496a-e054-00144ff8d46c	2025-05-28	Warnings	Exact identifier application number: M020
Celavive Protective Day SPF 30	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE	USANA Health Sciences, Inc.	cf00763f-6b3e-4d50-b639-9a6d6f595961	2025-05-28	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-092-83	53329009283	1 CONTAINER in 1 BOX (53329-092-83) / 4.2 g in 1 CONTAINER	1 container	2010-04-01	0000-00-00	No	No	Current