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 233 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	2cc8f7ef-eda3-fe71-e063-6394a90a6a9a	2025-01-28	Warnings	Exact identifier application number: M020
Baby Diaper Rash Cream	ZINC OXIDE	doTERRA International, LLC	641465a1-0daf-1bb9-e053-2a91aa0ab25d	2025-01-28	Warnings	Exact identifier application number: M020
HydroPeptide S.P.F. Sun Protection Friends	TITANIUM DIOXIDE, ZINC OXIDE	HydroPeptide LLC	f3669a1e-8b75-4e94-a3f0-71dcbc3fa914	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun Face Daily Moisturizer	ZINC OXIDE	doTERRA International, LLC	f3836517-e3ec-5e9e-e053-2a95a90a7af1	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun	ZINC OXIDE	doTERRA International, LLC	da5c48d6-1859-983d-e053-2a95a90a4c3e	2025-01-28	Warnings	Exact identifier application number: M020
doTERRA sun	ZINC OXIDE	doTERRA International, LLC	dd2fa6a2-2ba8-4333-e053-2a95a90a9790	2025-01-28	Warnings	Exact identifier application number: M020
Tri-water sheer mineral sunscreen cushion SPF30	ZINC OXIDE	Eden Brands Inc.	2cd22172-78cb-32f3-e063-6394a90a395d	2025-01-28	Warnings	Exact identifier application number: M020
SOS Face Guard Broad Spectrum Sunscreen SPF 30	ZINC OXIDE	Tower 28	6687006a-bd79-4e1c-a546-0f0b51b29948	2025-01-28	Warnings	Exact identifier application number: M020
LBEL CONCENTRE GLOBAL ANTI AGING SERUM CONCEALER SPF 15 EYES FACE ALMENDRA 230	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	2cb1a767-3228-71ea-e063-6294a90ac89e	2025-01-27	Warnings	Exact identifier application number: M020
Meijer SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	26f7566e-5a89-21cf-e063-6294a90ac886	2025-01-27	Warnings	Exact identifier application number: M020
TiZO Photoceutical AM Replenish Non-Tinted	ZINC OXIDE	Fallien Cosmeceuticals, LTD	2cb77125-ff77-2060-e063-6294a90ab69f	2025-01-27	Warnings	Exact identifier application number: M020
GLOW RECIPE WATERMELON GLOW DEW SHIELD HYDRATING FLUID SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Aramara Beauty LLC dba Glow Recipe	2cb90666-6517-a02c-e063-6294a90ab062	2025-01-27	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Z&Z Skin Essentials	2cdc48f3-474f-9c06-e063-6294a90afea1	2025-01-27	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Sunscreen Stick SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	54f6df65-e90c-4070-aa95-f47496dd11bd	2025-01-27	Warnings	Exact identifier application number: M020
Cetaphil Healthy Renew Day Cream Broad Spectrum SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Galderma Laboratories, L.P.	5b4e25ad-cd72-4960-9259-fc710bfd59da	2025-01-27	Warnings	Exact identifier application number: M020
Well People Daygleamer Liquid Mineral Sunscreen SPF 34	ZINC OXIDE	e.l.f. Cosmetics, Inc.	2c7621e9-0f1d-4712-e063-6294a90abd64	2025-01-24	Warnings	Exact identifier application number: M020
Equate Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	Wal-Mart Stores Inc	1697628a-91d2-45bc-bd1b-91fb38f3f8df	2025-01-24	Warnings	Exact identifier application number: M020
DR.JART EVERY SUN DAY SUN FLUID	HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Have & Be Co., Ltd.	f06d8f90-f3df-6d76-e053-2a95a90af1f8	2025-01-24	Warnings	Exact identifier application number: M020
CoTZ Silky Foam - Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	d63088d7-a1d7-4b56-a7d8-ad217011a8a8	2025-01-24	Warnings	Exact identifier application number: M020
CoTZ Silky Foam Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	9c04b76e-ae65-4183-b475-3b8e8764db59	2025-01-24	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