FDA.reportPublic FDA data

Mineral SPF 30 Whipped Sunscreen

Manufacturer
Sun Bum LLC
Effective date
2019-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:08:13

Label at a glance#

ProductMineral SPF 30 Whipped Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC 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 invert can and dispense liberally and spread evenly by hand 15 minutes before sun exposure do not dispense directely on face. Dispense into hands then apply to face do not apply in windy conditions  use in well-ventilated area 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 M...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 7.7%

Zinc oxide 6.9%

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

Flammable: do you not use near heat, flame, or while smoking

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.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F / 50°C.

Stop use and ask a doctor

OTC - STOP USE SECTION

if 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
  • invert can and dispense liberally and spread evenly by hand 15 minutes before sun exposure
  • do not dispense directely on face. Dispense into hands then apply to face
  • do not apply in windy conditions 
  • use in well-ventilated area
  • 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, propane, n-butane, isobutane, cococaprylate, butyloctyl salicylate, PEG-8 stearate, glyceryl stearate, cetearyl alcohol, sorbitan oleate, helianthus annuus (sunflower) seed extract, xylitylglucoside, anhydroxylitol, xylitol, glycerin, xanthan gum, polyhydroxystearic acid, triethoxycaprylylsilane, silica, dimethicone, dehydroacetic acid, benzyl alcohol, fragrance

Questions?

OTC - QUESTIONS SECTION

call 1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130871760007734GTIN-13: 0871760007734
EAN-13: 0871760007734
GTIN-12: 871760007734
UPC-A: 871760007734
GTIN storage (14 digits): 00871760007734		Label.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-281-002022-02-06C16284748780-1d6a99b39-b952-a426-e053-dadaa90af4c2Mineral SPF 30 Whipped Sunscreen
69039-281-002022-01-28C16284748780-1d6a99b39-b952-a426-e053-dadaa90af4c2Mineral SPF 30 Whipped Sunscreen

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-28169039-281-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANET75W9911L6IACT
BUTANE6LV4FOR43RIACT
ISOBUTANEBXR49TP611IACT
COCO-CAPRYLATE4828G836N6IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PEG-8 STEARATE2P9L47VI5EIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
XYLITYLGLUCOSIDEO0IEZ166FBIACT
ANHYDROXYLITOL8XWR7NN42FIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE92RU3N3Y1OIACT
DEHYDROACETIC ACID2KAG279R6RIACT
BENZYL ALCOHOLLKG8494WBHIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
d76656d8-72ef-627e-e053-2995a90add48eaeb0f63-a102-41b9-8420-04225cdaf2602022-02-06WarningsExact identifier
spl set id: eaeb0f63-a102-41b9-8420-04225cdaf260

Reported adverse events (FAERS/openFDA)#

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