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 284 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Safeway Signature Care Dry Touch Sunscreen SPF 55	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Safeway, Inc.	c6267a29-46a5-5f38-e053-2a95a90a0117	2024-10-14	Warnings	Exact identifier application number: M020
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30	ZINC OXIDE	Safeway, Inc.	dbeff8e8-250d-8274-e053-2995a90a984e	2024-10-14	Warnings	Exact identifier application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N	HOMOSALATE, ZINC OXIDE	Rare Beauty, LLC	2460281d-d433-0216-e063-6394a90a9d48	2024-10-13	Warnings	Exact identifier application number: M020
Walgreens 50 Coconut Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436987c-2afe-06b5-e063-6394a90aceba	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Banana Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2436bd19-2299-6e89-e063-6394a90acd99	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Clear Complexion Face Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f07238df-4970-7759-e053-2a95a90a39f9	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 70 Sport Continuous	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE	WALGREEN COMPANY	e7165b39-54f9-4af6-e053-2a95a90af664	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MIST	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f14bb3b4-1dce-06b9-e053-2995a90a8bc8	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Sport	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f12c9767-7cb7-12c8-e053-2995a90a17be	2024-10-11	Warnings	Exact identifier application number: M020
Sulwhasoo UV Daily Cream	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM	Amorepacific Corporation	e00451d5-8433-c4e8-e053-2a95a90a6244	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 50 Sport Continuous Sunscreen	AVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f13ec3da-2dc2-04f7-e053-2995a90a198d	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens SPF 30 Hydrating	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f4155692-16a7-11e8-e053-2995a90abd34	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	f906792b-083e-13e2-e053-6294a90ab4cf	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 Sunscreen	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	WALGREEN COMPANY	f9c81d88-8e28-fa53-e053-6394a90ac5c4	2024-10-11	Warnings	Exact identifier application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	fa18067a-310b-bdc3-e053-6394a90aee79	2024-10-11	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	24223fbf-8ce9-ec5e-e063-6294a90a29da	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	WALGREEN COMPANY	2422b327-ea83-f4c3-e063-6394a90a5c6e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Watermelon Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24256e54-ae34-91b2-e063-6394a90a33c0	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens 50 Premium Face Moisturizing Sunscreen	AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24265a48-fd07-c78a-e063-6394a90ab67e	2024-10-10	Warnings	Exact identifier application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	2410df0a-db52-0769-e063-6394a90a52f3	2024-10-09	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