SPF 15 Coconut Lip Balm

Product NDC: 84489-026
11-digit product format: 844890026
Labeler code: 84489
Product ID: 84489-026_25a7510f-5ef4-9920-e063-6394a90a2079
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide
Dosage form: STICK
Route: TOPICAL
Labeler: Naples Soap Company, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-02
Substance: ZINC OXIDE
Active strength: 35 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: SPF 15 Coconut Lip Balm
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	35 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	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
25a7510f-5ef3-9920-e063-6394a90a2079	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84489-026-96	SPF 15 Coconut Lip Balm	4.2 g in 1 CYLINDER	STICK	4.2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84489-026	SPF 15 SPEARMINT LIP BALM (ZINC OXIDE) STICK SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [NAPLES SOAP COMPANY, INC.]	1	Current NDC, 1 package rows	20241111_25a7510f-5ef3-9920-e063-6394a90a2079.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 203 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8a093b-cc9c-26fc-e063-6394a90a2028	2025-07-22	Warnings	Exact identifier application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8a87d6-ef86-60c2-e063-6394a90a0706	2025-07-22	Warnings	Exact identifier application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8b773c-f456-836a-e063-6294a90a0d46	2025-07-22	Warnings	Exact identifier application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8bc90d-350f-98c8-e063-6294a90abd9c	2025-07-22	Warnings	Exact identifier application number: M020
Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a8bd5d8-1c4c-0407-e063-6394a90a138f	2025-07-22	Warnings	Exact identifier application number: M020
CLEAR GLOW RADIANT SUN SERUM SPF50	AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN)	NAKED SUNDAYS PTY LTD	d748e291-3a29-663c-e053-2995a90a8d92	2025-07-22	Warnings	Exact identifier application number: M020
La Defense Broad Spectrum SPF 30 Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	Luzern Laboratories, Inc	3f00befa-415d-415d-89e1-6ba8770ba51e	2025-07-21	Warnings	Exact identifier application number: M020
PREDIRE PARIS skin shield protector mineral defense cream	PREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAM	Guangzhou Fantesy Biotechnology Co.,Ltd	3a7c1345-532f-b38f-e063-6394a90a5245	2025-07-21	Warnings	Exact identifier application number: M020
Medicated Peppermint Lip Balm	DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE	Blistex Inc	5d48a6fa-ddce-47c3-9b09-1f3abb695017	2025-07-18	Warnings	Exact identifier application number: M020
ICD Moisture Layer Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	ICD Moisture Layer Sunscreen	3a2a74f2-9fed-808f-e063-6294a90a410c	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 2	ZINC OXIDE	G2G Ventures, PBC	3a35c95b-10eb-689f-e063-6394a90ae1d4	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 3	ZINC OXIDE	G2G Ventures, PBC	3a35bbb2-a1eb-346b-e063-6294a90a9078	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4	ZINC OXIDE	G2G Ventures, PBC	3a35f23b-3732-db3c-e063-6294a90ae00c	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5	ZINC OXIDE	G2G Ventures, PBC	3a35fd79-f4d3-5ccf-e063-6294a90a9798	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6	ZINC OXIDE	G2G Ventures, PBC	3a360053-5863-95fe-e063-6394a90a45c5	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8	ZINC OXIDE	G2G Ventures, PBC	3a362e05-3a1e-8059-e063-6294a90ad525	2025-07-18	Warnings	Exact identifier application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7	ZINC OXIDE	G2G Ventures, PBC	3a3621c2-709a-82fd-e063-6294a90a7a7e	2025-07-18	Warnings	Exact identifier application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc	3a39ac31-85c9-5e04-e063-6394a90aa537	2025-07-18	Warnings	Exact identifier application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3afeda-f235-eac2-e063-6294a90a5a93	2025-07-18	Warnings	Exact identifier application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3a3b5f56-aa36-01c7-e063-6294a90a6d62	2025-07-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84489-026-96	84489002696	4.2 g in 1 CYLINDER (84489-026-96)	4.2 g	2022-08-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPF 15 Spearmint Lip Balm - Naples Soap Company, Inc.	Naples Soap Company, Inc.	2024-10-29	HUMAN OTC DRUG LABEL	1