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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPF30 Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	37d696d9-f89d-498e-8fe9-1f08d05d7b61	2024-04-18	Warnings	Exact identifier application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50	OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Galderma Laboratories, L.P.	6650d137-e69e-4ec2-8311-3de74bf21315	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e5e84e60-4339-460d-e053-2a95a90ad152	2024-04-17	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Eco Lips. Inc.	e64c4a2d-134e-999a-e053-2a95a90a64ee	2024-04-17	Warnings	Exact identifier application number: M020
SPF 30 Mineral Sunscreen Cariposa	TITANIUM DIOXIDE, ZINC OXIDE	Talent Brands Company LLC	0bc21573-d302-4d85-8d8f-dca9a48e1f35	2024-04-17	Warnings	Exact identifier application number: M020
Differin Oil Absorbing Moisturizer SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	4d5978c7-3575-4b5b-97bd-5f3c89412baf	2024-04-17	Warnings	Exact identifier application number: M020
Cancer Council Everyday Active SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16381c8f-f954-f0be-e063-6394a90ae401	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163a2994-d95a-5752-e063-6394a90aec5d	2024-04-16	Warnings	Exact identifier application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	163ac1c1-7403-9d60-e063-6294a90a1cc0	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil	OCTOCRYLENE, AVOBENZONE	Galderma Laboratories, L.P.	2a6bc3f2-4e52-252b-d051-94be1ee0cc00	2024-04-16	Warnings	Exact identifier application number: M020
Cetaphil Oil Absorbing SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Galderma Laboratories, L.P.	73ed545b-460f-4287-8643-a02b0641fd45	2024-04-16	Warnings	Exact identifier application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, ZINC OXIDE	SKINPLAN.US LLC	8e34a343-7253-469f-9973-076a7ae26cbc	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	1622c351-6e69-eeaf-e063-6294a90acd25	2024-04-15	Warnings	Exact identifier application number: M020
Hydrating Mineral Sunscreen BS SPF30	ZINC OXIDE	Allure Labs	16268c31-2151-20e0-e063-6294a90a7965	2024-04-15	Warnings	Exact identifier application number: M020
Cancer Council Daily Body Moisturizer SPF50 Plus	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Vitality US Co.	16296d3e-286a-e015-e063-6394a90a4189	2024-04-15	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	f9645435-e138-45df-a5ec-6dc7b3ff792d	2024-04-08	Warnings	Exact identifier application number: M020
Degil Sun SPF 50 Sunscreen	HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Degil Safety Products (1989) Inc	155aa0c5-6403-ee86-e063-6294a90a1c4d	2024-04-05	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	ff9eae5b-4963-429d-bb73-8e3b5402f084	2024-04-05	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products	15469260-d4e5-8423-e063-6394a90aafae	2024-04-04	Warnings	Exact identifier application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35	ZINC OXIDE	Allure Labs	1548faf9-8623-f871-e063-6394a90a931f	2024-04-04	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