FDA.reportPublic FDA data

Solbar Zinc SPF38

Product NDC
0096-0688
11-digit product format
000960688
Labeler code
0096
Product ID
0096-0688_4526b6bf-f3e7-0e65-e063-6394a90a6238
Type
HUMAN OTC DRUG
Nonproprietary name
Solbar Zinc SPF38
Dosage form
CREAM
Route
TOPICAL
Labeler
Person and Covey
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-06-01
Substance
HOMOSALATE; OCTINOXATE; ZINC OXIDE
Active strength
.1015; .077; .077 g/g; g/g; g/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
Solbar Zinc SPF38
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE.1015 g/g
OCTINOXATE.077 g/g
ZINC OXIDE.077 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
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
fac62a2f-92ee-4afd-9999-bc5011159e43Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0096-0688-04Solbar Zinc SPF38115 g in 1 BOTTLECREAM11511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0096-0688-04GM - Gram0096-0688bb6c1848-93aa-47d3-95c8-6510880ac91b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
HOMOSALATEACTIVE MOIETYV06SV4M95SSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
ZINC CATIONACTIVE MOIETY13S1S8SF37SOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
DIETHANOLAMINE CETYL PHOSPHATEINACTIVE INGREDIENT4UG0316V9SSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT)INACTIVE INGREDIENTXQQ9MKE2BJSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
GLYCERYL DILAURATEINACTIVE INGREDIENTMFL3ZIE8SKSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
ISOBUTYL STEARATEINACTIVE INGREDIENTV8DPR6HNX3SOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
WATERINACTIVE INGREDIENT059QF0KO0RSOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0096-0688SOLBAR ZINC SPF38 CREAM [PERSON AND COVEY]9Current NDC, Legacy NDC, 1 package rows20240102_fac62a2f-92ee-4afd-9999-bc5011159e43.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 180 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
application number: M020
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0096-0688-0400096068804115 g in 1 BOTTLE (0096-0688-04) 115 g1996-06-010000-00-00NoNoCurrent