FDA.reportPublic FDA data

SUNSCREEN

Manufacturer
ERBAVIVA INC.
Effective date
2012-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:12

Label at a glance#

ProductSUNSCREEN SPF 30
Active ingredientZINC OXIDE
Label structure14 sections

Storage and handling

OTHER INFORMATION PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
ZINC OXIDE 20%

OTC - PURPOSE SECTION

PURPOSE

SUNSCREEN

INDICATIONS & USAGE SECTION

  • HELPS PREVENT SUNBURN

WARNINGS SECTION

WARNINGS
  • FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

  • DO NOT USE ON DAMAGED OR BROKEN SKIN.

OTC - WHEN USING SECTION

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

OTC - STOP USE SECTION

  • AND ASK A DOCTOR IF RASH OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
• apply liberally 15 minutes before sun exposure.
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours

OTHER SAFETY INFORMATION

  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

PEDIATRIC USE SECTION

  • CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

INACTIVE INGREDIENT SECTION

Inactive ingredients: *Aloe barbadensis leaf juice, *anthemis nobilis (chamomile) flower oil, caprylic/capric triglycerides, *helianthus annuus (sunflower) seed oil, hydrogenated methyl abietate, *lavandula angustifolia (lavender) flower oil, magnesium sulfate, *olea europaea (olive) fruit oil, polyaminopropyl biguanide, polyglycerol-10 laurate, ricinus communis (castor) seed oil, *simmondsia chinensis (jojoba) seed oil, sorbitan stearate, tocopherol, water.

STORAGE AND HANDLING SECTION

OTHER INFORMATION
  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ERBAORGANICS

SPF30
BROAD SPECTRUM SUNSCREEN

Completely natural water resistant (80 minutes)
sunscreen for children and adults.

EBO_Sunscreen_LBL_2oz_20120318
EBO_Sunscreen_LBL_2oz_20120318

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43239-101-132019-11-13C16284748780-197449f38-ba35-f6ea-e053-dbdaa90aa703SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43239-101-13SUNSCREENSPF 3075 g in 1 TUBELOTION751

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43239-101SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [ERBAVIVA INC.]1Legacy NDC, 1 package rows20120319_3312d786-1a83-4bba-8b57-077df75293fd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALOEINACTIVE INGREDIENTV5VD430YW91
CASTOR OILINACTIVE INGREDIENTD5340Y2I9G1
CHAMAEMELUM NOBILE FLOWER OILINACTIVE INGREDIENTUB275878391
GLYCERYL ABIETATEINACTIVE INGREDIENT2F22LY70Q11
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1E1
POLYAMINOPROPYL BIGUANIDEINACTIVE INGREDIENT322U039GMF1
POLYGLYCERYL-10 OLEATEINACTIVE INGREDIENT55C81W76DH1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58X1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43239-10143239-101-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOEV5VD430YW9IACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
LAVENDER OILZBP1YXW0H8IACT
MAGNESIUM SULFATEDE08037SABIACT
OLIVE OIL6UYK2W1W1EIACT
POLYAMINOPROPYL BIGUANIDE322U039GMFIACT
POLYGLYCERYL-10 OLEATE55C81W76DHIACT
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
GLYCERYL ABIETATE2F22LY70Q1IACT

Source Document#

Source XML

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 2 · 63 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUPPOSITORY / VAGINALNAExact identifier — unii candidate
11 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7ULOTION / TOPICAL7 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSOLUTION / TOPICALNAExact identifier — unii candidate
11 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION / INTRAMUSCULAR885 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / ORAL62.5 mg/5mlExact identifier — unii candidate
11 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XTABLET / ORAL4 mgExact identifier — unii candidate
11 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSUSPENSION / TOPICAL2.15 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCREAM / TOPICAL3300 mgExact identifier — unii candidate
18 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / TOPICAL0.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, EXTENDED RELEASE / ORAL23.27 mgExact identifier — unii candidate
16 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOLUTION / ORAL425 mg/1mlExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSOLUTION / TOPICAL1.38 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGRANULE, FOR SUSPENSION / ORAL128 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE, EXTENDED RELEASE / ORAL47 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, FILM COATED / ORAL15.29 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ECAPSULE / ORALNAExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, EMULSION / INTRAVENOUS1.1 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8INHALANT / NASALNAExact identifier — unii candidate
2 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XCREAM / TOPICAL177 mgExact identifier — unii candidate
11 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GCAPSULE / ORAL1.04 mgExact identifier — unii candidate
16 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CAPSULE, COATED / ORAL0.25 mgExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, COATED / ORAL0.9 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XSPRAY / TOPICAL4.58 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ESOAP / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
16 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8INJECTION, EMULSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, EXTENDED RELEASE / ORAL0.37 mgExact identifier — unii candidate
18 equally ranked IID candidates
MAGNESIUM SULFATEMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XLOTION / TOPICAL89 mgExact identifier — unii candidate
11 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GOINTMENT / TOPICAL14.9 %w/wExact identifier — unii candidate
16 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
OLIVE OILOLIVE OIL6UYK2W1W1ELOTION / TOPICAL32468 mgExact identifier — unii candidate
5 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GGEL / NASAL429 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GINJECTION, SOLUTION / INTRAMUSCULAR525 mgExact identifier — unii candidate
16 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
SORBITAN MONOSTEARATESORBITAN MONOSTEARATENVZ4I0H58XAEROSOL, FOAM / TOPICAL0.55 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GTABLET / ORAL17 mgExact identifier — unii candidate
16 equally ranked IID candidates
CASTOR OILCASTOR OILD5340Y2I9GSPRAY / NASALNAExact identifier — unii candidate
16 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
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
65dba14a-31fa-4eef-8853-e9462219a8323312d786-1a83-4bba-8b57-077df75293fd2012-03-18WarningsExact identifier
spl id: 65dba14a-31fa-4eef-8853-e9462219a832
spl set id: 3312d786-1a83-4bba-8b57-077df75293fd

Reported adverse events (FAERS/openFDA)#

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