StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT

Manufacturer: Strivectin Operating Company, Inc.
Effective date: 2015-03-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:32:16

Label at a glance#

ProductStriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT

Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE

Label structure7 sections

Indications and uses

helps prevent sunburn

Dosage and administration

• apply liberally 15 minutes before sun exposure • reapply at least every two 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 value of 15 or higher and other sun protection measures including: • limit time in the s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.50%
Octisalate 3.00%
Titanium Dioxide 8.00%

Purpose

OTC - PURPOSE SECTION

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

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 at least every two 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 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
• children under 6 months of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water, Eau), Cyclopentasiloxane, Butylene Glycol, PEG-10 Dimethicone, Myristyl Nicotinate, Isododecane, Phenyl Trimethicone, Aluminum Hydroxide, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Root Extract, Olive Glycerides, Ceramide 3, Caprylyl Glycol, Polyamide-5, Nylon-12, Bis-PEG/PPG-14/14 Dimethicone, Boron Nitride, Disteardimonium Hectorite, Sodium Dehydroacetate, Methicone, Triethosycaprylylsilane, Sodium Chloride, Hexylene Glycol, Mica, Disodium EDTA, Phenoxyethanol. May Contain +/-: CI 77891 (Titanium Dioxide), CI 77491/77492/77499 (Iron Oxides)

Other information

SPL UNCLASSIFIED SECTION

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

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Light - CartonLight - Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76147-210-01	2022-02-09	C162847	48780-1	9d75b9d0-9dab-f424-e053-dadaa90a57ce	StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT
76147-210-01	2020-01-31	C162847	48780-1	9d75b9d0-9dab-f424-e053-dadaa90a57ce	StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
BIS-PEG/PPG-14/14 DIMETHICONE	INACTIVE INGREDIENT	X2I70H0QJE	1
BORON NITRIDE	INACTIVE INGREDIENT	2U4T60A6YD	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
ISODODECANE	INACTIVE INGREDIENT	A8289P68Y2	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
MYRISTYL NICOTINATE	INACTIVE INGREDIENT	8QWM6I035C	1
NYLON-12	INACTIVE INGREDIENT	446U8J075B	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

StriVectin Clinical Corrector ADVANCED ANTI-AGING FACE TINT LIGHT
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
OCTINOXATE
OCTISALATE
TITANIUM DIOXIDE
CYCLOMETHICONE 5
BUTYLENE GLYCOL
MYRISTYL NICOTINATE
ISODODECANE
PHENYL TRIMETHICONE
ALUMINUM HYDROXIDE
STEARIC ACID
TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE
TETRAHEXYLDECYL ASCORBATE
VITAMIN A PALMITATE
HYALURONATE SODIUM
GLYCYRRHIZA GLABRA
CERAMIDE 3
CAPRYLYL GLYCOL
NYLON-12
BIS-PEG/PPG-14/14 DIMETHICONE
BORON NITRIDE
DISTEARDIMONIUM HECTORITE
SODIUM DEHYDROACETATE
SODIUM CHLORIDE
HEXYLENE GLYCOL
MICA
EDETATE DISODIUM
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76147-210	76147-210-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
CYCLOMETHICONE 5	0THT5PCI0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
MYRISTYL NICOTINATE	8QWM6I035C	IACT
ISODODECANE	A8289P68Y2	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TOCOPHEROL	R0ZB2556P8	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
TETRAHEXYLDECYL ASCORBATE	9LBV3F07AZ	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
CERAMIDE 3	4370DF050B	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
NYLON-12	446U8J075B	IACT
BIS-PEG/PPG-14/14 DIMETHICONE	X2I70H0QJE	IACT
BORON NITRIDE	2U4T60A6YD	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
HEXYLENE GLYCOL	KEH0A3F75J	IACT
MICA	V8A1AW0880	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	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 · 320 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SOFT TISSUE		26 mg	Exact identifier — unii candidate 134 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
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / RETROBULBAR		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SPRAY, METERED / NASAL		36 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 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
d79e1cf1-adbc-0f2d-e053-2995a90af31b			a24bb991-0b7d-47c9-9f60-7f81dfa61c27	2022-02-09	Warnings	Exact identifier spl set id: a24bb991-0b7d-47c9-9f60-7f81dfa61c27

Reported adverse events (FAERS/openFDA)#

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