FDA.reportPublic FDA data

ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30

Manufacturer
OMP, Inc. | Swiss-American Products
Effective date
2014-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:53

Label at a glance#

ProductROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: 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 includi...

Storage and handling

store at controlled room temperature: 15°C-25°C (59°F-77°F). protect this product 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 2.0%Sunscreen
Zinc Oxide 15.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

OTC - STOP USE SECTION

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor

  • if rash occurs

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

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
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

alumina, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, coco-glucoside, dipropylene glycol, ethylparaben, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iron oxides, isobutylparaben, isohexadecane, isopropyl titanium triisostearate/triethoxycaprylylsilane crosspolymer, methylparaben, mica, PEG-6, phenoxyethanol, polyhydroxystearic acid, propylparaben, titanium dioxide, tocopheryl acetate, triethoxycaprylylsilane, water

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature: 15°C-25°C (59°F-77°F).
  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

1.800.636.7546
Monday-Friday 9 a.m.-4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies.

Distributed by OMP, Inc., Long Beach, CA 90806

©2013 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.

www.obagi.com
Made in USA

10726414Z 7264
Rev. 12/13

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI®
MEDICAL

rosaclear®

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION
BROAD SPECTRUM SPF 30
SUNSCREEN LOTION

Net wt. 3 oz. (85 g)

Principal Display Panel - 85 g Bottle Label
Principal Display Panel - 85 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62032-072-642020-01-31C16284748780-19d75b9d0-657d-f424-e053-dadaa90a57ceROSACLEAR ® SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNSCREEN LOTION

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62032-072ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30 SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OMP, INC.]1Legacy NDC20141013_affadfae-ce06-42b6-a044-ee621d6ea727.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225B1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
MICAINACTIVE INGREDIENTV8A1AW08801
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQ1
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0F1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
62032-07262032-072-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
WATER059QF0KO0RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIPROPYLENE GLYCOLE107L85C40IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO GLUCOSIDEICS790225BIACT
METHYLPARABENA2I8C7HI9TIACT
ALUMINUM OXIDELMI26O6933IACT
PROPYLPARABENZ8IX2SC1OHIACT
ISOHEXADECANE918X1OUF1EIACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLPARABEN14255EXE39IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
BUTYLPARABEN3QPI1U3FV8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

Source Document#

Source XML · Source PDF

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 6 · 328 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, DELAYED RELEASE / ORAL3 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, DELAYED RELEASE / ORAL7 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE, COATED / ORAL0.01 mgExact identifier — unii candidate
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TEMULSION / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAVENOUS0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, CHEWABLE / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRADERMAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / NASAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
POLYETHYLENE GLYCOL 300POLYETHYLENE GLYCOL 3005655G9Y8AQINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS44.22 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 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
bfedbefb-e1e5-4028-815c-a7853ac22901affadfae-ce06-42b6-a044-ee621d6ea7272026-02-12WarningsExact identifier
spl set id: affadfae-ce06-42b6-a044-ee621d6ea727

Reported adverse events (FAERS/openFDA)#

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