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 121 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Bio H Plus Daily Defense And Revitalize	ZINC OXIDE	BIOHEALTH PLUS LLC	3765331e-ad4b-5661-e063-6294a90a7c20	2025-12-15	Exact identifier application number: M020
Facial Mineral Fusion	TITANIUM DIOXIDE, ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35944621-e6fb-cd98-e063-6294a90aa641	2025-12-15	Exact identifier application number: M020
Face Love	ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d043a7-7269-469f-e063-6294a90a1a4d	2025-12-15	Exact identifier application number: M020
Mineral Mousse	TITANIUM DIOXIDE, ZINC OXIDE	CLARITY SKIN CARE STUDIO, INC.	35d00778-3857-ce8f-e063-6394a90ab375	2025-12-15	Exact identifier application number: M020
Chem-Free Sunscreen Non-Tinted Formula	ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	3594d573-c680-62c9-e063-6294a90a4229	2025-12-15	Exact identifier application number: M020
Chem Free Sunscreen Tinted Formula	ZINC OXIDE	IT INTELLIGENT TREATMENT LLC	35948531-37ef-1fce-e063-6294a90ae79b	2025-12-15	Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	35933039-8beb-9f98-e063-6394a90a60bb	2025-12-15	Exact identifier application number: M020
Simply Protected Tinted Mineral Sunscreen	ZINC OXIDE	Healthy Skin & Body LLC	380416b9-180a-3904-e063-6294a90a7bee	2025-12-15	Exact identifier application number: M020
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	R. Sonia Batra, MD, Inc.	3592edca-cab0-6c44-e063-6294a90a1727	2025-12-15	Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38046e71-f171-7e96-e063-6294a90a1f0b	2025-12-15	Exact identifier application number: M020
Barrier Plus Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Healthy Skin & Body LLC	38038beb-d0f0-ced2-e063-6294a90ac423	2025-12-15	Exact identifier application number: M020
Extreme Protection Non Tinted	ZINC OXIDE	BIOHEALTH PLUS LLC	3764cbeb-55f5-4a9c-e063-6394a90a863d	2025-12-15	Exact identifier application number: M020
Happy Mineral Sunscreen Primer SPF	TITANIUM DIOXIDE, ZINC OXIDE	ACNE CLINIC LAS VEGAS BY JUSTINA	37d9c5f2-f414-6efa-e063-6294a90a927f	2025-12-15	Exact identifier application number: M020
Comfort Mineral Mousse Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BIOHEALTH PLUS LLC	3765dd17-ffbd-bcf4-e063-6394a90a2c2b	2025-12-15	Exact identifier application number: M020
Prime And Protect Dewy	ZINC OXIDE	Kalon Skin Studio, LLC	3593cefe-a08f-eb88-e063-6394a90aaff6	2025-12-15	Exact identifier application number: M020
Glow	ZINC OXIDE	GODDESSLYNNEBODYANDSKIN	37247365-33ee-563d-e063-6394a90a249e	2025-12-15	Exact identifier application number: M020
Prime And Protect Matte	TITANIUM DIOXIDE, ZINC OXIDE	Kalon Skin Studio, LLC	35939630-1166-1c70-e063-6294a90aac6b	2025-12-15	Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36d9d83b-7da5-a006-e063-6394a90a9d84	2025-12-15	Exact identifier application number: M020
Non-Tinted 20% Zinc Mineral Sunscreen	ZINC OXIDE	BELLA MEDICAL SKIN CARE	36da1a55-c076-cdd9-e063-6294a90ac97c	2025-12-15	Exact identifier application number: M020
Tinted Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Goldberg, Howard S MD Inc	3598205d-2e87-9292-e063-6294a90a1f2a	2025-12-15	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