FDA.reportPublic FDA data

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 190 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - SandbarHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac57c70-9298-cbe7-e063-6394a90aefc12025-08-27WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 sunscreenHOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezeda01f0ab9-d686-4ee1-be39-fd4c061cb0182025-08-26WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d48d467-4b6b-c477-e063-6294a90a5a0d2025-08-26WarningsExact identifier
application number: M020
PAPATUI Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEPAPATUI, LLC3d4ab3a5-a29b-bdd9-e063-6294a90a542c2025-08-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 sunscreenHOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezed34ffc25c-16e3-4c7c-9d46-9d9f279c074b2025-08-26WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36da7117-1c8e-7fcf-e063-6294a90aed002025-08-26WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36dc7c13-eaf7-b415-e063-6294a90a57842025-08-26WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1b7f0c-fdc2-df22-e063-6294a90aed412025-08-26WarningsExact identifier
application number: M020
Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1c8b83-f37d-a29d-e063-6294a90a20a82025-08-26WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen Tanning OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c468710-ca71-79be-e063-6394a90a8cfd2025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50SUNSCREENSoleil Collective LLC3d4c90e7-0716-4d57-e063-6394a90a43fa2025-08-26WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c4433e2-d383-8326-e063-6294a90aaf982025-08-26WarningsExact identifier
application number: M020
Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50SUNSCREENSoleil Collective LLC3d4d1b94-b1ce-cf94-e063-6394a90a61ba2025-08-26WarningsExact identifier
application number: M020
naked TURTLE 30ZINC OXIDENAKED TURTLE SUNSCREEN LLC65f1570a-6156-40e6-a792-e0707607dc2f2025-08-26WarningsExact identifier
application number: M020
Sky and Sol Sunscreen SPF 50ZINC OXIDEDelta Ecommerce LLC2d490531-af38-87d0-e063-6394a90acf492025-08-25WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC20d24c9d-9558-156d-e063-6294a90a2d1a2025-08-25WarningsExact identifier
application number: M020
Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC413275e8-0011-471e-9539-ea95ed8384132025-08-25WarningsExact identifier
application number: M020
Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 - BananaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d34d144-2515-d7fa-e063-6294a90abb3f2025-08-25WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 sunscreenAVOBENZONE 3.0%, HOMOSALATE 15.0%, OCTISALATE 5.0%, OCTOCRYLENE 8.0%Florida Squeezed393b59aa-6d5a-4757-9f6d-59f7533aee862025-08-25WarningsExact 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