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 285 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Broad Spectrum SPF 40 Radiant Facial Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	24114416-33b9-c6ba-e063-6394a90a6f3b	2024-10-09	Warnings	Exact identifier application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	WALGREEN COMPANY	0c40a46b-b9f9-8e14-e063-6394a90a9573	2024-10-09	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	531f60c9-c89a-46bc-8460-d01b2e838e6f	2024-10-08	Warnings	Exact identifier application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	AMOREPACIFIC CORPORATION	60964d9f-d96c-4397-b273-6b63d1886722	2024-10-08	Warnings	Exact identifier application number: M020
IOPE AIR CUSHION Cover 21 Vanilla	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	29d6cc8d-1469-479d-a15a-e78d4e22d4a2	2024-10-08	Warnings	Exact identifier application number: M020
IOPE UV DEFENSE SUN PROTECTOR	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0f2a87f7-2185-16a5-e063-6294a90a92a3	2024-10-08	Warnings	Exact identifier application number: M020
Tropical Topical Matte SPF30	ZINC OXIDE	Allure Labs	039fba4b-720a-9199-e063-6394a90adbfb	2024-10-08	Warnings	Exact identifier application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	AMOREPACIFIC CORPORATION	0e746836-ed84-7b33-e063-6294a90aeff3	2024-10-08	Warnings	Exact identifier application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	PureTek Corporation	86eb06cc-d63f-4500-a52e-14ef99a56532	2024-10-02	Warnings	Exact identifier application number: M020
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a	2024-10-01	Warnings	Exact identifier application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreen	ZINC OXIDE	Fallien Cosmeceuticals, LTD	231af290-99ee-e94d-e063-6394a90a0bef	2024-09-27	Warnings	Exact identifier application number: M020
Target Up and Up SPF 70 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	23085ab9-5abb-a572-e063-6394a90ae34a	2024-09-26	Warnings	Exact identifier application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and Ceramides	HOMOSALATE, OCTOCRYLENE, ZINC OXIDE	TARGET CORPORATION	23598ad1-12a3-fe65-e063-6394a90a4f6f	2024-09-26	Warnings	Exact identifier application number: M020
Target Up and Up SPF 30 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	22f59a88-02d7-ebdb-e063-6394a90a957b	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen Stick	ZINC OXIDE	TARGET CORPORATION	22f7c376-7289-04bf-e063-6394a90a1459	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	TARGET CORPORATION	22f86630-d4b4-8ad7-e063-6394a90a8d1e	2024-09-25	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Mineral Zinc Oxide Sunscreen	ZINC OXIDE	TARGET CORPORATION	22f9044a-f54c-b34b-e063-6394a90a88ee	2024-09-25	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE ,OCTOCRYLENE	Edgewell Personal Care Brands LLC	22e2b447-bd6b-5e8a-e063-6394a90a0de9	2024-09-24	Warnings	Exact identifier application number: M020
Luminous Defense SPF 50	ZINC OXIDE	Levels 2 Skin	22e177b3-beea-212e-e063-6394a90a1452	2024-09-24	Warnings	Exact identifier application number: M020
Target Up and Up SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	22e359cd-4c63-b124-e063-6394a90aec73	2024-09-24	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