ROSACLEAR ® SKIN BALANCING SUN PROTECTION SPF 30 SUNSCREEN LOTION

Manufacturer: OMP, Inc. | Swiss-American Products
Effective date: 2011-12-30
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:47:32

Label at a glance#

ProductROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection.

Dosage and administration

apply liberally before sun exposure and as needed. children under 6 months of age: ask a doctor. reapply as needed or after towel drying, swimming, or sweating.

Storage and handling

store at controlled room temperature: 15-25°C (59-77°F). Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Titanium Dioxide 2.0%	Sunscreen
Zinc Oxide 15.5%	Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn
higher SPF gives more sunburn protection.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

rash or irritation develops and lasts.

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 before sun exposure and as needed.
children under 6 months of age: ask a doctor.
reapply as needed or after towel drying, swimming, or sweating.

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature: 15-25°C (59-77°F).
Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alumina, Butylparaben, Cetearyl Alcohol, Coco-Glucoside, C12-15 Alkyl Benzoate, Dipropylene Glycol, PEG-6, Ethylparaben, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isobutylparaben, Isohexadecane, Isopropyl Titanium Triisostearate/Triethoxycaprylylsilane Crosspolymer, Methylparaben, Mica, Phenoxyethanol, Polyhydroxystearic Acid, Propylparaben,Tocopheryl Acetate, Triethoxycaprylylsilane, Water.

SPL UNCLASSIFIED SECTION

Dist. by OMP, Inc.
3760 Kilroy Airport Way Suite 500
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OBAGI^®
MEDICAL

rosaclear^®
system

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION
SPF 30
SUNSCREEN LOTION

3 FL.OZ. (88 mL)

Principal Display Panel - 88 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62032-103-90	2019-11-13	C162847	48780-1	97449f38-bf3f-f6ea-e053-dbdaa90aa703	ROSACLEAR ® SKIN BALANCING SUN PROTECTION SPF 30 SUNSCREEN LOTION

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62032-103	ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [OMP, INC.]	1	Legacy NDC	20120426_8017e35e-ddf7-4d57-84b4-7e591448095e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN
TITANIUM DIOXIDE and ZINC OXIDE
TITANIUM DIOXIDE
ZINC OXIDE
ALKYL (C12-15) BENZOATE
WATER
POLYHYDROXYSTEARIC ACID (2300 MW)
DIPROPYLENE GLYCOL
POLYETHYLENE GLYCOL 300
CETOSTEARYL ALCOHOL
COCO GLUCOSIDE
METHYLPARABEN
ALUMINUM OXIDE
PROPYLPARABEN
ISOHEXADECANE
MICA
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
ALPHA-TOCOPHEROL ACETATE
TRIETHOXYCAPRYLYLSILANE
ETHYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
PHENOXYETHANOL
GLYCERIN
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62032-103	62032-103-90

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
Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
ALKYL (C12-15) BENZOATE	A9EJ3J61HQ	IACT
WATER	059QF0KO0R	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
DIPROPYLENE GLYCOL	E107L85C40	IACT
POLYETHYLENE GLYCOL 300	5655G9Y8AQ	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
COCO GLUCOSIDE	ICS790225B	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
ISOHEXADECANE	918X1OUF1E	IACT
MICA	V8A1AW0880	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
ETHYLPARABEN	14255EXE39	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
GLYCERIN	PDC6A3C0OX	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT

Source Document#

Source XML

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 ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 300	POLYETHYLENE GLYCOL 300	5655G9Y8AQ	SOLUTION / INTRAVENOUS		16920 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
POLYETHYLENE GLYCOL 300	POLYETHYLENE GLYCOL 300	5655G9Y8AQ	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	44.22 %w/v		Exact identifier — unii candidate 13 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, COATED / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYETHYLENE GLYCOL 300	POLYETHYLENE GLYCOL 300	5655G9Y8AQ	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SYRUP / ORAL	28.4 mg/1ml		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CAPSULE, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POLYETHYLENE GLYCOL 300	POLYETHYLENE GLYCOL 300	5655G9Y8AQ	TABLET / ORAL		1 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED / ORAL	0.01 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYETHYLENE GLYCOL 300	POLYETHYLENE GLYCOL 300	5655G9Y8AQ	SOLUTION / TOPICAL	29.7 %w/w		Exact identifier — unii candidate 13 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
71d5392b-5e25-4455-baf6-c2f96aefe53f			8017e35e-ddf7-4d57-84b4-7e591448095e	2026-02-12	Warnings	Exact identifier spl set id: 8017e35e-ddf7-4d57-84b4-7e591448095e

Reported adverse events (FAERS/openFDA)#

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