TITANIUM DIOXIDE and ZINC OXIDE

Manufacturer
Orveon Global US LLC
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:21

Label at a glance#

ProductbareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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

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

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium dioxide 3.28%Sunscreen
Zinc oxide 12.48%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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • For sunscreen use:
    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
  • 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-sleeved shirts, pants, hats and sunglasses.
  • children under 6 months: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, c9-12 alkane, dimethicone, propanediol, glycerin, PEG-32, PEG-6, polyglyceryl-4 laurate/succinate, polysorbate 60, camellia japonica flower extract, bupleurum falcatum root extract, undaria pinnatifida extract, hypericum erectum flower/leaf/stem extract, moringa oleifera seed extract, theobroma cacao (cocoa) seed extract, lactobacillus ferment, ceramide np, manganese pca, butylene glycol, succinoglycan, biosaccharide gum-4, bisabolol, allantoin, phytosteryl/octyldodecyl, lauroyl glutamate, aminopropyl dimethicone, lauryl betaine, cetyl stearate, isostearyl isostearate, aluminum hydroxide, decyl isostearate, polyquaternium-51, sodium hyaluronate, ascorbyl glucoside, mica, cellulose gum, silica, sodium pca, coco-caprylate/caprate, decyl glucoside, potassium cetyl phosphate, cetyl alcohol, isohexadecane, caprylyl glycol, hexylene glycol, sorbitan oleate, 1,2-hexanediol, sorbitan sesquiisostearate, sodium methyl stearoyl taurate, vp/eicosene copolymer, polyacrylate crosspolymer-6, t-butyl alcohol, polysorbate 80, disodium edta, dimethylacrylamide/sodium acryloyldimethyltaurate crosspolymer, polysilicone-11, disodium phosphate, isostearic acid, sodium citrate, hydrogen dimethicone, sodium acrylate/sodium acryloyldimethyl taurate copolymer, stearic acid, citric acid, triethoxycaprylylsilane, tocopherol, tin oxide, alcohol, fragrance, limonene, linalool, hexyl cinnamal, sodium benzoate, phenoxyethanol. may contain: titanium dioxide, iron oxides.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bareMinerals

COMPLEXION
RESCUE
DEFENSE

RADIANT
PROTECTIVE VEIL

Broad Spectrum SPF 30
Sunscreen

50 ml/1.7 fl. oz.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-000-60bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30Soft Radiance50 mL in 1 TUBECREAM504
98132-000-60bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30Soft Radiance1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-000BAREMINERALS COMPLEXION RESCUE DEFENSE RADIANT PROTECTIVE VEIL BROAD SPECTRUM SPF 30 SOFT RADIANCE (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ORVEON GLOBAL US LLC]4Current NDC, Legacy NDC, 2 package rows20231207_0c2db44d-8604-4883-ab01-f14bc441e4e4.zip

Products#

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

DailyMed product names page 1 of 2 · 71 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
98132-00098132-000-60

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 69 matching rows.

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
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft RadianceTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC0c2db44d-8604-4883-ab01-f14bc441e4e42023-10-04WarningsExact identifier
ndc (package): 98132-000-60
ndc (product): 98132-000
ndc11 (package): 98132000060
spl id: 06e761d0-9eeb-3e5a-e063-6394a90ab72c
spl set id: 0c2db44d-8604-4883-ab01-f14bc441e4e4

Reported adverse events (FAERS/openFDA)#

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