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 229 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quick Screen Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	The Quick Flick PTY LTD	3788666e-7efa-43da-95f5-6218b7fcb6ea	2025-02-12	Warnings	Exact identifier application number: M020
Dolce AND Gabbana Get Your Healthy Glowy Skin	ZINC OXIDE	Socoplan	91bf1cca-8d18-4c59-864d-4fd0619c6713	2025-02-12	Warnings	Exact identifier application number: M020
Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CMS LAB Inc.	2dfd1f99-5896-1e0f-e063-6394a90aa71d	2025-02-12	Warnings	Exact identifier application number: M020
Biore Aqua Rich UV	OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE	KAO USA	f9024581-dbab-b7cb-e053-6294a90a8b9a	2025-02-12	Warnings	Exact identifier application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40	ZINC OXIDE	Dr. Loretta, LLC	ebdaf6c1-1572-4840-851b-6d780471fcb2	2025-02-11	Warnings	Exact identifier application number: M020
Sky and Sol Body Sunscreen SPF50	SKY AND SOL BODY SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	2de9173b-fa02-8017-e063-6394a90ae0aa	2025-02-11	Warnings	Exact identifier application number: M020
Beeswax SPF 15 Broad Spectrum Lip Balm	BEESWAX SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	2dcc2f9b-4a8c-b281-e063-6294a90ad9d6	2025-02-10	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 Tropical Sunscreen	BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN	Raining Rose, Inc	2dcca380-c0e4-4e04-e063-6394a90ac31e	2025-02-10	Warnings	Exact identifier application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Deep	ENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE	Amway Corp	88021a24-d3b5-48f8-8d26-affbfcfd098f	2025-02-10	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Sheer)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2dd20800-2cf9-02d4-e063-6294a90a0f00	2025-02-10	Warnings	Exact identifier application number: M020
Bondi Sands Fragrance Free Face SPF 50 Sunscreen Mist	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BONDI SANDS (USA) INC.	2dd5ea23-eee6-5d14-e063-6294a90a0fd3	2025-02-10	Warnings	Exact identifier application number: M020
Centella Calming SUNSCREEN	CENTELLA CALMING SUNSCREEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	2dc0ee9b-d58b-fe40-e063-6394a90af439	2025-02-09	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR ROSY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc25afb-a171-f1f2-e063-6294a90ae333	2025-02-09	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTOR BERRY	AVOBENZONE, HOMOSALATE, OCTISALATE	PERENNEBELL Co., Ltd	2dc285ad-08cd-14e6-e063-6294a90a24fc	2025-02-09	Warnings	Exact identifier application number: M020
PROBIOTIC RICE Sunscreen	PROBIOTIC RICE SUNSCREEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	2d9d6440-39b3-312a-e063-6394a90aa072	2025-02-08	Warnings	Exact identifier application number: M020
NIA 24 SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	Niadyne Inc	e5c9d56f-48b4-4f0e-add6-f73268755b16	2025-02-07	Warnings	Exact identifier application number: M020
Pacific Mango Sunscreen SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	SAN DIEGO NATURAL SOAP COMPANY	d09e3096-0678-4433-a555-61f18a45873b	2025-02-06	Warnings	Exact identifier application number: M020
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cfe6a6-c2e4-8fb8-e063-6294a90adc78	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a8bab8-ca5d-6b65-e063-6294a90abb07	2025-02-06	Warnings	Exact identifier application number: M020
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a82029-bdb1-cbe0-e063-6294a90a08f3	2025-02-06	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