LBel

Manufacturer: Ventura Corporation Ltd. | BelStar, S.A.
Effective date: 2011-08-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:50:52

Label at a glance#

ProductLBel Protege Expert

Active ingredientOctinoxate, Octisalate, Octocrylene, Oxybenzone, Titanium dioxide

Label structure10 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. Provides high protection against sunburn Retains SPF after 40 minutes of activity in the water.

Dosage and administration

Apply liberally before sun exposure and as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%, Titanium dioxide 1%

Purpose

OTC - PURPOSE SECTION

sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides high protection against sunburn
Retains SPF after 40 minutes of activity in the water.

Warnings

WARNINGS SECTION

For external use only.

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 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

Other information

SPL UNCLASSIFIED SECTION

Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ozokerite, hydrogenated vegetable oil, petrolatum, butyrosperum parkii (butyrospermum parkii (shea butter)), ricinus communis seed oil (ricinus communis (castor ) seed oil), c12-15 alkyl benzoate, isopropyl lanolate, paraffin, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), isopropyl myristate, bht, propylparaben, tocopheryl acetate, octyldodecanol, cera microcristallina (microcrystalline wax), bha, phospholipids, cholesterol, cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, euphorbia cerifera (candelilla) wax, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids

SPL UNCLASSIFIED SECTION

US: Dist. by Ventura International Ltd, San Francisco, CA 94111.
P.R.: Dist. by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 5 g Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL

PROTÈGE
EXPERT

sunscreen for eyes
contour and lips
SPF 30

WATER RESISTANT

5 g e (.17 oz.)

UVB SPF
30
Moderate
Protection
UVA
PA ++

PRINCIPAL DISPLAY PANEL - 5 g Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13537-028-02	2025-02-20	C162847	48780-1	960f7f55-d8bc-8e05-e053-dbdaa90a074a	L'BEL PROTÈGE EXPERT sunscreen for eyes contour and lips SPF 30
13537-028-02	2019-10-29	C162847	48780-1	960f7f55-d8bc-8e05-e053-dbdaa90a074a	L'BEL PROTÈGE EXPERT sunscreen for eyes contour and lips SPF 30

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Titanium dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	1
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
Titanium dioxide	ACTIVE MOIETY	15FIX9V2JP	1
alkyl (c12-15) benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	1
butylated hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	1
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	1
cetearyl glucoside	INACTIVE INGREDIENT	09FUA47KNA	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
microcrystalline wax	INACTIVE INGREDIENT	XOF597Q3KY	1
octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

LBel Protege Expert
Octinoxate, Octisalate, Octocrylene, Oxybenzone, and Titanium dioxide
Octinoxate
Octisalate
Octocrylene
Oxybenzone
Titanium dioxide
petrolatum
shea butter
castor oil
alkyl (c12-15) benzoate
paraffin
carnauba wax
isopropyl myristate
butylated hydroxytoluene
propylparaben
octyldodecanol
microcrystalline wax
butylated hydroxyanisole
cholesterol
yellow wax
cetostearyl alcohol
cetearyl glucoside
candelilla wax

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
13537-028	13537-028-01, 13537-028-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Titanium dioxide	15FIX9V2JP	ACTIB
petrolatum	4T6H12BN9U	IACT
shea butter	K49155WL9Y	IACT
castor oil	D5340Y2I9G	IACT
alkyl (c12-15) benzoate	A9EJ3J61HQ	IACT
paraffin	I9O0E3H2ZE	IACT
carnauba wax	R12CBM0EIZ	IACT
isopropyl myristate	0RE8K4LNJS	IACT
butylated hydroxytoluene	1P9D0Z171K	IACT
propylparaben	Z8IX2SC1OH	IACT
octyldodecanol	461N1O614Y	IACT
microcrystalline wax	XOF597Q3KY	IACT
butylated hydroxyanisole	REK4960K2U	IACT
cholesterol	97C5T2UQ7J	IACT
yellow wax	2ZA36H0S2V	IACT
cetostearyl alcohol	2DMT128M1S	IACT
cetearyl glucoside	09FUA47KNA	IACT
candelilla wax	WL0328HX19	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 5 · 244 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
microcrystalline wax	MICROCRYSTALLINE WAX	XOF597Q3KY	CAPSULE, EXTENDED RELEASE / ORAL	6 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	TABLET / ORAL	0.7 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
cholesterol	CHOLESTEROL	97C5T2UQ7J	INJECTABLE, LIPOSOMAL / INFILTRATION	0.47 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
cholesterol	CHOLESTEROL	97C5T2UQ7J	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
butylated hydroxyanisole	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
butylated hydroxyanisole	BUTYLATED HYDROXYANISOLE	REK4960K2U	TABLET / ORAL		8 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
butylated hydroxyanisole	BUTYLATED HYDROXYANISOLE	REK4960K2U	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
microcrystalline wax	MICROCRYSTALLINE WAX	XOF597Q3KY	OINTMENT / TOPICAL		3575 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
cholesterol	CHOLESTEROL	97C5T2UQ7J	INJECTION / INTRAVENOUS		93 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
octyldodecanol	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii candidate 11 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 / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
octyldodecanol	OCTYLDODECANOL	461N1O614Y	FILM, EXTENDED RELEASE / TRANSDERMAL	253.4 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
octyldodecanol	OCTYLDODECANOL	461N1O614Y	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, FOR SUSPENSION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
cholesterol	CHOLESTEROL	97C5T2UQ7J	LOTION / TOPICAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL / TOPICAL		8 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
butylated hydroxyanisole	BUTYLATED HYDROXYANISOLE	REK4960K2U	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	AEROSOL, FOAM / TOPICAL		14235 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
butylated hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
isopropyl myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
cholesterol	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		7 mg	Exact identifier — unii candidate 10 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
2e9a9b74-c89d-6d26-e063-6294a90aa677			b34907a5-fe3c-4c64-8d18-dee217bae0e2	2025-02-20	Warnings	Exact identifier spl set id: b34907a5-fe3c-4c64-8d18-dee217bae0e2

Reported adverse events (FAERS/openFDA)#

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