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 82 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Blue Lizard Baby SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d6e04a-fa30-ba48-e063-6394a90a1bbf	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f780daa-4c91-5a68-e063-6394a90afd41	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sensitive SPF 50	ZINC OXIDE	Crown Laboratories	99839894-9695-2cd1-e053-2995a90acba6	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard SPF 15 Lip Balm	ZINC OXIDE	Crown Laboratories	1bf8fb7e-9d5b-86d4-e063-6294a90afddc	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Kids SPF 50	ZINC OXIDE	Crown Laboratories	9983563c-1e63-0748-e053-2a95a90a971e	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Baby SPF 50	ZINC OXIDE	Crown Laboratories	9948f5b8-43bd-1c99-e053-2a95a90a6121	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sheer SPF 50 Sunscreen	ZINC OXIDE	Crown Laboratories	3368f1cb-c341-e886-e063-6394a90a9b7c	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sport SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f3844d8-0367-aad9-e063-6294a90a1fce	2026-01-12	Warnings	Exact identifier application number: M020
Blue Lizard Sheer Face SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	30cd79da-2f25-a42a-e063-6394a90a8332	2026-01-12	Warnings	Exact identifier application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN	TITAMIUN DIOXIDE, ZINC OXIDE	UCL Co., Ltd.	4837b4f6-ada9-801a-e063-6294a90a8547	2026-01-12	Warnings	Exact identifier application number: M020
Intellishade Original SPF 45	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e213a681-eb22-69c0-e053-2995a90a899e	2026-01-12	Warnings	Exact identifier application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASE	HOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	48393640-4b97-04de-e063-6294a90aa6a6	2026-01-12	Warnings	Exact identifier application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30	ZINC OXIDE	Eclectic Solutions LLC	0530904f-b02c-d8cf-e063-6294a90aa5a7	2026-01-12	Warnings	Exact identifier application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Minori Inc.	1d4e2654-1638-0d01-e063-6394a90af303	2026-01-12	Warnings	Exact identifier application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30	ZINC OXIDE	JANE STREET LLC	15e9d688-f226-1a19-e063-6394a90ab906	2026-01-12	Warnings	Exact identifier application number: M020
BROAD SPECTRUM SPF50 SPF 50	AVOBENZONE, HOMOSALATE OCTISALATE,	NAKED SUNDAYS PTY LTD	0426b1e9-063b-c1e6-e063-6294a90a2554	2026-01-11	Warnings	Exact identifier application number: M020
SPF30 MINERAL SUNSCREEN MOUSSE	ZINC OXIDE	Aopline Biotechnology (Guangzhou) Co., Ltd.	48031a0f-c2ed-5424-e063-6294a90ad0ff	2026-01-10	Warnings	Exact identifier application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMER	ZINC OXIDE	Aopline Biotechnology (Guangzhou) Co., Ltd.	48037a05-722e-4231-e063-6294a90ac51f	2026-01-10	Warnings	Exact identifier application number: M020
ODLUMIVIE Tinted Mineral Sunscreen	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Meijiao Medical Biotechnology Co., Ltd.	480d6e65-f6dc-d2a5-e063-6294a90a24a1	2026-01-10	Warnings	Exact identifier application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	FUTURE 8 LLC	9922f132-f6a5-41ca-847a-936b20bf1716	2026-01-09	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