FDA.reportPublic FDA data

Mineral SPF 30 Lotion

Manufacturer
Sun Bum LLC
Effective date
2019-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:05:56

Label at a glance#

ProductMineral SPF 30
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

shake well before use apply liberally 15 minutes before sun exposure reapply:- after 80 minutes of swimming or sweating  immediately after towel drying at least every 2 hours children under 6 months of age: ask a doctor 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 value of 15 or ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 14.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product 

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:- after 80 minutes of swimming or sweating 
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age: ask a doctor

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 value 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-sleeved shirts, pants, hats and sunglasses

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cocos nucifera (coconut) oil, butyloctyl salicylate, diheptyl succinate, capryloyl glycerin/sebacic acid copolymer, methyl dihydroabietate, butyro spermum parkii (shea butter), cetearyl alcohol, sodium stearoyl glutamate, theobroma cacao (cocoa) seed butter, tocopherol, cocoglucoside, microcrystalline cellulose, fragrance, cetyl alcohol, behenyl alcohol, bisabolol, arachidyl, glucoside, phenoxyethanol, arachidyl alcohol, cellulose gum, sodium hyaluronate, sodium gluconate, citric acid, ethylhexylglycerin, polyhydroxystearic acid

Questions?

OTC - QUESTIONS SECTION

call 1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130871760008144GTIN-13: 0871760008144
EAN-13: 0871760008144
GTIN-12: 871760008144
UPC-A: 871760008144
GTIN storage (14 digits): 00871760008144		Label2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-284-012022-02-05C16284748780-1d6a99b39-50c5-a426-e053-dadaa90af4c2Mineral SPF 30 Lotion
69039-284-012022-01-28C16284748780-1d6a99b39-50c5-a426-e053-dadaa90af4c2Mineral SPF 30 Lotion

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-28469039-284-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIHEPTYL SUCCINATE057N7SS26YIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SHEA BUTTERK49155WL9YIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT
COCO GLUCOSIDEICS790225BIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CETYL ALCOHOL936JST6JCNIACT
DOCOSANOL9G1OE216XYIACT
LEVOMENOL24WE03BX2TIACT
.BETA.-D-GLUCOPYRANOSEJ4R00M814DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM GLUCONATER6Q3791S76IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
d7409685-ea53-304c-e053-2a95a90a5a946367ac0e-5d3f-4103-99d9-1d9ceadba3832022-02-05WarningsExact identifier
spl set id: 6367ac0e-5d3f-4103-99d9-1d9ceadba383

Reported adverse events (FAERS/openFDA)#

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