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 63 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
All Day Moisture	HOMOSALATE, ZINC OXIDE	Walmart Inc.	b45d0ab6-b14d-4e3e-807a-886e6fffdded	2026-02-11	Warnings, Adverse reactions	Exact identifier application number: M020
Ganrek SUNSCREEN SPRAYER Broad Spectrum SPF 50	SUNSCREEN SPF 50	Guangzhou Meixi Biotechnology Co., Ltd.	4a3adb04-5e3a-80bf-e063-6294a90a6047	2026-02-10	Warnings	Exact identifier application number: M020
Sugargirl Glow Up Body Illuminator Shimmer Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	364d4d87-2d3e-4515-a3f2-1506d871699d	2026-02-10	Warnings	Exact identifier application number: M020
Sugargirl Sunshine Body Illuminator Glowy Sunscreen SPF 30	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ea801e6c-44f9-4ec9-9022-5b637baf7d59	2026-02-10	Warnings	Exact identifier application number: M020
Poolside Golden Hour SPF 15 Sunscreen Lip	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	7d0f8319-f0fa-4ea7-bb66-427c5a78145a	2026-02-10	Warnings	Exact identifier application number: M020
Tanri Broad Spectrum SPF 30	SUNSCREEN	I. Shay Cosmetics	26d5b9d1-d669-3430-e063-6394a90ad7f2	2026-02-10	Warnings	Exact identifier application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30	ZINC OXIDE	S+	9d6ffe56-debc-4ad2-837b-fd7bb091a56f	2026-02-09	Warnings	Exact identifier application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a9c970c8-b6e3-b0a1-e053-2a95a90a89c7	2026-02-09	Warnings	Exact identifier application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - Face	ZINC OXIDE	Solavida, LLC	4a694cdf-496b-3bc0-e063-6294a90af0d1	2026-02-09	Warnings	Exact identifier application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	BENOW BEAUTY INC	32bfb17c-5535-c016-e063-6394a90a1814	2026-02-09	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	4a6b69ed-2739-d22a-e063-6294a90a1e52	2026-02-09	Warnings	Exact identifier application number: M020
SUNPLUS LIP LIFE	SUNSCREEN	I. Shay Cosmetics	26d28286-e812-0fb3-e063-6394a90a338d	2026-02-09	Warnings	Exact identifier application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess Glow	ZINC OXIDE SUNSCREEN	Bentley Laboratories, LLC	bb86322d-ff30-4a54-97b5-1be275067146	2026-02-06	Warnings	Exact identifier application number: M020
Hampton Sun SPF 50 Mineral	ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	d6c33436-042e-44e8-8b55-98be6e246879	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER	OCTINOXATE, TITANIUM DIOXIDE	Shiseido Americas Corporation	f291f077-1c72-48fc-bb19-c20bdeaaa596	2026-02-06	Warnings	Exact identifier application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROL	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Shiseido Americas Corporation	f225a736-2ff7-4084-88a4-a8df5b043cce	2026-02-06	Warnings	Exact identifier application number: M020
Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	American Sales Company	79dff6ec-d958-4bba-999b-da4aa67519f5	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avobenzone, Homosalate, Octisalate, Octocrylene	SUNSCREEN	Retail Business Services, LLC	1dc325bb-d520-4897-b8f8-3f0ecba2274c	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	d8a55217-ae50-4c7f-a440-f4de079d08ae	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M020
Sheer Touch Sunscreen SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE	Retail Business Services, LLC	f2a4b432-118e-42a4-baeb-90614dccbd06	2026-02-06	Warnings, Adverse reactions	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