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
IngredientStrength
ZINC OXIDE11 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab6a326d-3b93-4122-a9f2-05e8203d31efAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73054-104-01SOLARA SUNCARE - POUT PROTECTORSPF-1510 mL in 1 TUBECREAM109
73054-104-11SOLARA SUNCARE - POUT PROTECTORSPF-151 in 1 BOXCREAM19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73054-104SOLARA SUNCARE - POUT PROTECTOR SPF-15 (ZINC OXIDE) CREAM [SOLARA SUNCARE, INC.]8Current NDC, Legacy NDC, 2 package rows20240816_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 172 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Light 210 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.2f151e6c-ab2d-40cb-a67c-e067147ed7022025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 280 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6b0b9204-f205-415b-bd16-1970958b8be72025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 240 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8c12a34c-f648-4b55-8265-d430c72ae2052025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Light 250 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 370 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8d4862e-2671-4b85-8338-f935e0d0194f2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 310 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8d53abee-73bc-4268-b08d-0c196ff4d8522025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Medium 375 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.1de296f5-276b-4e8f-8db2-78ea01965c4a2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 610 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.75543b93-8ed9-4c7b-9fcf-99745df5a1942025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 620 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.798eecb3-ff6e-46d1-9053-b40e9cd02e5c2025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
application number: M020
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
application number: M020
SEKKISEI HERBAL UV DEFENSE gelAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKOS America, Inc.cb0faa3a-68f8-49c5-8c28-3338b1b27cd82025-10-31WarningsExact identifier
application number: M020
Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 VeilZINC OXIDETHG Beauty USA LLC2c749a52-adaa-2609-e063-6294a90a8fc22025-10-30WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4260e410-d2d5-71b4-e063-6294a90a05b82025-10-30WarningsExact identifier
application number: M020
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
application number: M020
WEIGHTLESS PROTECTION SPF 30OCTINOXATE, ZINC OXIDE, OCTISALATEBotanical Science Technologiesde9a97b8-6633-4d71-e053-2995a90a5e8f2025-10-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73054-104-017305401040110 mL in 1 TUBE10 mlHistorical
73054-104-11730540104111 TUBE in 1 BOX (73054-104-11) / 10 mL in 1 TUBE (73054-104-01) 1 tube2019-07-060000-00-00NoNoCurrent