COOLA Classic Body Sunscreen Pina Colada

Product NDC: 54111-146
11-digit product format: 541110146
Labeler code: 54111
Product ID: 54111-146_7d0440d0-91bd-4c66-86d7-5e4722d1951a
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE
Dosage form: LOTION
Route: TOPICAL
Labeler: Bentley Laboratories, LLC
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-11-06
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 1.75; 2.5; 1.5; 3.75 g/100mL; g/100mL; g/100mL; g/100mL
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54111-146-50	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54111-146-50	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54111-146-50	`bd6a592717d7…`	`303034d00443…`

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: COOLA Classic Body Sunscreen Pina Colada
Brand name suffix: SPF 30
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AVOBENZONE	1.75 g/100mL
HOMOSALATE	2.5 g/100mL
OCTISALATE	1.5 g/100mL
OCTOCRYLENE	3.75 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
d508cef6-977f-4231-8c19-491569e99921	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54111-146-50	2023-01-04	C162847	48780-1	d6a99b39-3873-a426-e053-dadaa90af4c2	COOLA CLASSIC BODY SUNSCREEN PINA COLADA Broad Spectrum SPF 30
54111-146-50	2022-01-28	C162847	48780-1	d6a99b39-3873-a426-e053-dadaa90af4c2	COOLA CLASSIC BODY SUNSCREEN PINA COLADA Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54111-146-50	COOLA Classic Body Sunscreen Pina ColadaSPF 30	148 mL in 1 TUBE	LOTION	148		5
54111-146-50	COOLA Classic Body Sunscreen Pina ColadaSPF 30	1 in 1 BOX	LOTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54111-146	COOLA CLASSIC BODY SUNSCREEN PINA COLADA SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [BENTLEY LABORATORIES, LLC]	5	Current NDC, Legacy NDC, 2 package rows	20231221_d508cef6-977f-4231-8c19-491569e99921.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 84 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Play Lip Balm with Acai Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	9f5b54c7-a424-6917-e053-2a95a90ac627	2026-01-09	Warnings	Exact identifier application number: M020
Everyday Sunscreen with Sunflower Extract Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE	Supergoop, LLC	81b9fda2-bd55-1b90-e053-2991aa0a765a	2026-01-09	Warnings	Exact identifier application number: M020
Play Lip Balm Broad Spectrum SPF 30 with Mint	AVOBENZONE, HOMOSALATE, OCTISALATE,	Supergoop, LLC	9f6cd243-ef5c-df8a-e053-2a95a90a4e36	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Sun Silk Body Sunglow 05 Fragrance SPF 30 Sunscreen Body	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	4416ad39-a4b5-4238-9792-c7f475d1e561	2026-01-09	Warnings	Exact identifier application number: M020
Lip Screen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	a3e5819a-5132-9760-e053-2a95a90a058b	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Orange Creme SPF 30 Scented Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	d96a1390-27be-452a-818b-0ba6127e9f96	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Daybreak Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	4554d9a8-33a1-4299-8a57-dab72980b2eb	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	b5be8ea7-3408-4495-9a50-3328f7698738	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen For the Face	HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE	I World LLC	c99464d1-a5bb-4140-a95e-25d6b383616c	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen Light	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	1fabd546-55e5-4ab2-8a1b-7b161bfbb866	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen Medium	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	876a6f88-8dac-4303-8acb-525999c93528	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Glowy Face Screen Sunbeam Shimmer Sunscreen For the Face SPF 30	HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONE	I World LLC	f6316c4f-076a-4ba5-a526-0e20e5156ced	2026-01-09	Warnings	Exact identifier application number: M020
Sugargirl Set Screen SPF 30 Setting Sunscreen Translucent	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	0a3bae73-141b-4a47-be35-c5708dfb1180	2026-01-09	Warnings	Exact identifier application number: M020
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1	TITANIUM DIOXIDE	Amway Corp	4345cdf6-e220-4e7c-8abd-da59d2b7db84	2026-01-09	Warnings	Exact identifier application number: M020
Mineral Sheer Screen Broad Spectrum Sunscreen SPF 30	ZINC OXIDE	Supergoop LLC	b47ed3bf-92a8-9bc9-e053-2a95a90a8eee	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Hydra-Ceramide Boost Broad Spectrum Sunscreen SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	ca5520a1-4c43-cb32-e053-2a95a90a97f5	2026-01-09	Warnings	Exact identifier application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop LLC	d6fcc065-cbcd-0b81-e053-2a95a90ab1f9	2026-01-09	Warnings	Exact identifier application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b9590938-417d-617a-e053-2995a90a7496	2026-01-09	Warnings	Exact identifier application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop LLC	d7758651-c152-5868-e053-2a95a90ab673	2026-01-09	Warnings	Exact identifier application number: M020
Mineral Sunscreen SPF 30	ZINC OXIDE	Supergoop, LLC	4cf243b4-d794-401a-b209-18c7e550ef4f	2026-01-09	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54111-146-50	54111014650	1 TUBE in 1 BOX (54111-146-50) / 148 mL in 1 TUBE	1 tube	2019-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COOLA CLASSIC BODY SUNSCREEN PINA COLADA Broad Spectrum SPF 30	Bentley Laboratories, LLC	2023-12-19	HUMAN OTC DRUG LABEL	5