FDA.reportPublic FDA data

UNBLEMISH Shine Free

Manufacturer
Rodan & Fields
Effective date
2019-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:42

Label at a glance#

ProductUNBLEMISH Shine Free
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. lf 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

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 15or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.-...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3%

Zinc Oxide 14%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • lf 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

  • Apply liberally 15 minutes before sun exposure.
  • Reapply every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 15or 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.
  • Children under 6 months: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water,Cyclopentasiloxane,Dimethicone, Butyloctyl Salicylate, PEG-10 Dimethicone, Pentylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butylene Glycol, Hexyl Laurate, Polysilicone-11, Tocopheryl Acetate, Boerhavia Diffusa Root Extract, Sodium PCA, Tetrahexyldecyl Ascorbate, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Cholesterol, Glycerin, Sorbitan Stearate, Oleanolic Acid, Polyglyceryl-4 lsostearate, Sorbitan lsostearate, Squalane, Stearic Acid, Fragrance, Alumina, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Methylcellulose Stearoxy Ether, Ammonium Polyacryloyldimethyl Taurate, Polysorbate 10, Polysorbate 60, Polysorbate 80, lsohexadecane, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Sodium Metabisulfite, Caprylyl Glycol, 1,2-Hexanediol, Chlorphenesin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol.

Questions

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel - 30 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

UNBLEMISH

4 Shine-Free
Lotion

Broad Spectrum

SPF 20 Sunscreen

RODAN+FIELDS

30 mL/1.0 Fl. Oz. U.S.

Principal Display Panel - 30 mL Carton Label
Principal Display Panel - 30 mL Carton Label

Principal Display Panel - 30 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

UNBLEMISH

4 Shine-Free
Lotion

Broad Spectrum

SPF 20 Sunscreen

Principal Display Panel - 30 mL Tube Label
Principal Display Panel - 30 mL Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2130-12021-01-29C16284748780-1ba0f9c33-434d-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2130-1UNBLEMISH Shine Free1 in 1 CARTONLOTION11
14222-2130-1UNBLEMISH Shine Free30 mL in 1 TUBELOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2130UNBLEMISH SHINE FREE (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RODAN & FIELDS]1Legacy NDC, 2 package rows20190306_54ae05c8-a62c-4503-b49e-53d85d79b9ee.zip

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-213014222-2130-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
PENTYLENE GLYCOL50C1307PZGIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HEXYL LAURATE4CG9F9W01QIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINUM OXIDELMI26O6933IACT
BOERHAVIA DIFFUSA ROOTKR0SR09KYLIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
CHLORPHENESINI670DAL4SZIACT
CHOLESTEROL97C5T2UQ7JIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (600000 CST)RKI3S914RTIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOHEXADECANE918X1OUF1EIACT
OLEANOLIC ACID6SMK8R7TGJIACT
PEG-100 STEARATEYD01N1999RIACT
PEG-60 ALMOND GLYCERIDES4Y0E651N0FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SQUALANEGW89575KF9IACT

Source Document#

Source XML · Source PDF

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
f93181e8-8dc4-47e6-bdf6-7227fd60b1af54ae05c8-a62c-4503-b49e-53d85d79b9ee2019-02-13WarningsExact identifier
spl id: f93181e8-8dc4-47e6-bdf6-7227fd60b1af
spl set id: 54ae05c8-a62c-4503-b49e-53d85d79b9ee

Reported adverse events (FAERS/openFDA)#

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