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 158 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Sun Tinted Face SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	22413f93-7219-4726-b741-2392e576b34a	2025-11-24	Warnings	Exact identifier application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15	ZINC OXIDE AND TITANIUM DIOXIDE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	28e23498-953f-47c0-838c-bbf0e858d903	2025-11-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c9d86-45d7-efcc-e063-6394a90acefb	2025-11-23	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	615c5349-7fff-4145-9d65-1687247163be	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	3cee59ad-f5e1-487d-b9cc-597664c62dac	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0e905f47-a1d8-4c5a-8247-d7328d2cb4af	2025-11-21	Warnings	Exact identifier application number: M020
SPF 50 Sport Sunscreen GoodSense	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Geiss, Destin, & Dunn, Inc	a22baebd-1f4d-6eae-e053-2a95a90afe51	2025-11-21	Warnings	Exact identifier application number: M020
Everyday Sun Defense	ZINC OXIDE	Hommerejuvenate, Inc.	05aa1a1a-9e4f-2781-e063-6394a90aef6b	2025-11-21	Warnings	Exact identifier application number: M020
innisfree Daily UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, AND OCTISALATE LOTION	Innisfree Corporation	0e9b6697-28a3-f69f-e063-6394a90a9d11	2025-11-20	Warnings	Exact identifier application number: M020
SULWHASOO PERFECTING CUSHION NO. 25	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Amorepacific Corporation	8d420e4b-c778-3ed4-e053-2995a90a59a9	2025-11-20	Warnings	Exact identifier application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Norwex Usa, Inc.	f527a8c5-b05e-5f3c-e053-2995a90aa1a3	2025-11-20	Warnings	Exact identifier application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	Norwex Usa, Inc.	440bd831-ee0b-b527-e063-6294a90a9333	2025-11-20	Warnings	Exact identifier application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Elemis Ltd.	23f9222f-60ba-72fb-e063-6394a90a9965	2025-11-20	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca866e-adc3-5a4f-e063-6394a90a1d1d	2025-11-20	Warnings	Exact identifier application number: M020
Sandra Plasencia Green Tea Daily SPF 50 Moisturizer	TITANIUM DIOXIDE	Sandra Plasencia Skincare	43ef1f93-0e89-0a35-e063-6394a90afb51	2025-11-19	Warnings	Exact identifier application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50	ZINC OXIDE	Sunkissed By Heaven, LLC	09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d	2025-11-19	Warnings	Exact identifier application number: M020
KOVR Military grade sunscreen for women	ZINC OXIDE	ACTIVE LIFE INC	4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae	2025-11-19	Warnings	Exact identifier application number: M020
Dynamic Resurfacing SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	fc64720c-060c-4f33-8c76-96456fac270d	2025-11-19	Warnings	Exact identifier application number: M020
Daily Defence Shield SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	b2b6de93-47c8-4b6e-9fb9-8bdc8909271a	2025-11-19	Warnings	Exact identifier application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32	ZINC OXIDE	DUKE CANNON SUPPLY CO.	0c47278b-2ec2-81ab-e063-6294a90ac937	2025-11-19	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