SOLARA SUNCARE - POUT PROTECTOR

Product NDC: 73054-104
11-digit product format: 730540104
Labeler code: 73054
Product ID: 73054-104_4690f7ee-2f52-3b32-e063-6394a90a806d
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: SOLARA SUNCARE, INC.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-07-06
Substance: ZINC OXIDE
Active strength: 11 g/100mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
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: SOLARA SUNCARE - POUT PROTECTOR
Brand name suffix: SPF-15
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	11 g/100mL

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
ab6a326d-3b93-4122-a9f2-05e8203d31ef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73054-104-01	SOLARA SUNCARE - POUT PROTECTORSPF-15	10 mL in 1 TUBE	CREAM	10		9
73054-104-11	SOLARA SUNCARE - POUT PROTECTORSPF-15	1 in 1 BOX	CREAM	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73054-104	SOLARA SUNCARE - POUT PROTECTOR SPF-15 (ZINC OXIDE) CREAM [SOLARA SUNCARE, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240816_ab6a326d-3b93-4122-a9f2-05e8203d31ef.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 252 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fresh Coast SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	043cadde-ba07-7c77-e063-6394a90abee6	2024-12-19	Warnings	Exact identifier application number: M020
Black Girl Sunscreen SPF 30	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Derma Care Research Labs, LLC	d438be95-0f88-69d7-e053-2995a90a982e	2024-12-19	Warnings	Exact identifier application number: M020
Pavin SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	e945f9df-0aed-469c-e053-2995a90ab6aa	2024-12-19	Warnings	Exact identifier application number: M020
Bee Bald Smooth Plus Daily Moisturizer SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 6%	Derma Care Research Labs, LLC	051b68f9-5d6b-3cd7-e063-6394a90aeb35	2024-12-19	Warnings	Exact identifier application number: M020
MKMen Advanced Facial Hydrator Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Mary Kay Inc.	484e92db-09a2-4e93-aa7e-d91dbda31555	2024-12-19	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Unfragranced	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	05e4706b-1955-aba8-e063-6294a90a29c7	2024-12-19	Warnings	Exact identifier application number: M020
Rubber Ducky SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	cf32b3a0-de88-b866-e053-2a95a90a3f32	2024-12-19	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Rocky Mountain	AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%	Derma Care Research Labs, LLC	a216d48f-4ed4-6008-e053-2a95a90a8c9a	2024-12-19	Warnings	Exact identifier application number: M020
Rod and Rifle SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%	Derma Care Research Labs, LLC	fc61847b-cb61-97b1-e053-6394a90ae1b9	2024-12-19	Warnings	Exact identifier application number: M020
Habana Brisa SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6%	Derma Care Research Labs, LLC	db0d6dec-d0ee-6160-e053-2a95a90a2c6e	2024-12-19	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 30 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8%	Derma Care Research Labs, LLC	f8730f9c-43c1-f4d3-e053-6294a90a1809	2024-12-19	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	f8735925-dcb2-6723-e053-6294a90a51f4	2024-12-19	Warnings	Exact identifier application number: M020
Caribbean Breeze SPF 70 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	f873c125-86b8-3d1d-e053-6394a90a6bcf	2024-12-19	Warnings	Exact identifier application number: M020
Royal Boost Cover Me Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	efd7d887-0616-4c76-84d8-5370eb63cb7f	2024-12-19	Warnings	Exact identifier application number: M020
Rubber Ducky SPF 50 Unfragranced Sunscreen	AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6%	Derma Care Research Labs, LLC	043b447c-4519-37ce-e063-6394a90a7197	2024-12-19	Warnings	Exact identifier application number: M020
Australian Sands SPF 50 Sunscreen	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	f886a02f-c043-b281-e053-6294a90af746	2024-12-19	Warnings	Exact identifier application number: M020
SPF 50 Sunscreen Rocky Mountain	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Derma Care Research Labs, LLC	a1c9066c-4801-5aee-e053-2995a90a75d2	2024-12-19	Warnings	Exact identifier application number: M020
Dr. Throwers SPF 30 Face and Body Sunscreen	AVOBENZONE 3%, HOMOSALATE 12%, OCTISALATE 5%, OCTOCRYLENE 3%	Derma Care Research Labs, LLC	d680b6f6-e1a9-47a4-e053-2a95a90ae3b0	2024-12-19	Warnings	Exact identifier application number: M020
Vacation Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	29a7636c-4d99-2cac-e063-6394a90a7480	2024-12-19	Warnings	Exact identifier application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 CARAMEL	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	COSMAX USA, INC	29a82ba9-c0f8-0edf-e063-6294a90a50b4	2024-12-19	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	Marketing end	Sample	Exclude flag	Status
73054-104-01	73054010401	10 mL in 1 TUBE	10 ml					Historical
73054-104-11	73054010411	1 TUBE in 1 BOX (73054-104-11) / 10 mL in 1 TUBE (73054-104-01)	1 tube	2019-07-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SOLARA (as PLD) - POUT PROTECTOR SPF-15 (73054-104)	SOLARA SUNCARE, INC.	2025-12-22	HUMAN OTC DRUG LABEL	9