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 163 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunsolve MD Firm and Replenish	ZINC OXIDE	Sunsolve MD Inc	26f3417b-9ea4-e577-e063-6294a90ae53c	2025-11-14	Warnings	Exact identifier application number: M020
Sunsolve MD Correct and Fade	ZINC OXIDE	Sunsolve MD Inc	26f3ad9f-f8ca-05d4-e063-6394a90ad5c4	2025-11-14	Warnings	Exact identifier application number: M020
Sunsolve MD Volumize and Condition Lip	ZINC OXIDE	Sunsolve MD	396b7462-d597-4bf7-e063-6394a90ab58d	2025-11-14	Warnings	Exact identifier application number: M020
Sunsovle MD Volumize and Restore	ZINC OXIDE	Sunsolve MD Inc	26f3cdda-b990-15cb-e063-6394a90ade29	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew-Glow Moisturizer SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc	0a5b80fb-caeb-eb56-e063-6294a90a238b	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d82f310-f87a-f76d-e063-6294a90af251	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-deep	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d865e74-1baf-6a44-e063-6394a90a37ac	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-medium	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d8616a8-2eab-c85c-e063-6294a90a3984	2025-11-14	Warnings	Exact identifier application number: M020
Naturium UV Reflect Antioxidant SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc	0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c	2025-11-14	Warnings	Exact identifier application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	372894af-bed7-474f-95d4-69a8c3f215ef	2025-11-14	Warnings	Exact identifier application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ONEAND CO., LTD.	2dc41560-f4a7-5f0b-e063-6294a90a0630	2025-11-13	Warnings	Exact identifier application number: M020
Covey Sun and Done Daily Moisturizing	ZINC OXIDE	Covey Skin	fbcf8204-0673-99aa-e053-6294a90ac26e	2025-11-13	Warnings	Exact identifier application number: M020
SOL Science The Fifty	ZINC OXIDE	Beauty Pie	01548858-8b0e-494a-e063-6294a90a8e99	2025-11-13	Warnings	Exact identifier application number: M020
Balmere Mineral Sunscreen Moisturizer Primer	ZINC OXIDE	Balmere	00d813e0-eb97-a6ba-e063-6394a90aa525	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	437eb2a8-428c-8339-e063-6394a90a74b2	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	437f4db5-552f-1550-e063-6394a90aaedb	2025-11-13	Warnings	Exact identifier application number: M020
Depology Essential Mineral UV Care	ZINC OXIDE	Depology Holdings LLC	1d48cdee-be67-14c0-e063-6294a90a7422	2025-11-13	Warnings	Exact identifier application number: M020
Hanalei Face Moisturizing	ZINC OXIDE	Hanalei Beauty Company LLC	1f7c1a68-5aea-0deb-e063-6394a90a3a43	2025-11-13	Warnings	Exact identifier application number: M020
Glo Skin	TITANIUM DIOXIDE, ZINC OXIDE	Glo Skin Beauty	f4bed574-68c1-0d2c-e053-2a95a90a15ff	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	4380036a-7698-03e7-e063-6294a90a7301	2025-11-13	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