FDA.reportPublic FDA data

Solbar Zinc SPF38

Manufacturer
Person and Covey
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:30:57

Label at a glance#

ProductSolbar Zinc SPF38
Active ingredientHOMOSALATE, OCTINOXATE, ZINC OXIDE
Label structure8 sections

Dosage and administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

Label contents#

Full prescribing information#

Indications and use

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Yes. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

OTC - ACTIVE INGREDIENT SECTION

Homosalate

Octinoxate

Zinc Oxide

INACTIVE INGREDIENT SECTION

Water

Isobutyl Stearate

PEG-100 Stearate

Glycerin

Dimethicone

PVP/Eicosene Copolymer

Glyceryl Dilaurate

Cetyl Alcohol

DEA Cetyl Phosphate

Benzyl Alcohol

Cyclomethicone

Stearyl Alcohol

Xanthan Gum

Disodium EDTA

Citric Acid

Solbar Zinc

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solbar ZincSolbar Zinc

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
IngredientTypeUNIISPL versionUploaded
HOMOSALATEACTIVE INGREDIENTV06SV4M95S1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
ZINC CATIONACTIVE MOIETY13S1S8SF371
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIETHANOLAMINE CETYL PHOSPHATEINACTIVE INGREDIENT4UG0316V9S1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT)INACTIVE INGREDIENTXQQ9MKE2BJ1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL DILAURATEINACTIVE INGREDIENTMFL3ZIE8SK1
ISOBUTYL STEARATEINACTIVE INGREDIENTV8DPR6HNX31
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0096-06880096-0688-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOBUTYL STEARATEV8DPR6HNX3IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT)XQQ9MKE2BJIACT
GLYCERYL DILAURATEMFL3ZIE8SKIACT
CETYL ALCOHOL936JST6JCNIACT
DIETHANOLAMINE CETYL PHOSPHATE4UG0316V9SIACT
BENZYL ALCOHOLLKG8494WBHIACT
CYCLOMETHICONENMQ347994ZIACT
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
EDETATE SODIUMMP1J8420LUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-10-28monthly-update2026-06-03 17:38:19
92024-01-01full-release2026-06-01 00:06:22

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LULOTION / TOPICAL0.17 %w/wExact identifier — unii+route
10 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOAP / TOPICAL0.12 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / TOPICAL0.3 %w/wExact identifier — unii+route
10 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solbar Zinc SPF38SOLBAR ZINC SPF38Person and Coveyfac62a2f-92ee-4afd-9999-bc5011159e432025-12-04WarningsExact identifier
ndc (package): 0096-0688-04
ndc (product): 0096-0688
ndc11 (package): 00096068804
spl id: 4526b6bf-f3e7-0e65-e063-6394a90a6238
spl set id: fac62a2f-92ee-4afd-9999-bc5011159e43

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.