Solar Protection Formula SPF 65

Manufacturer: Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date: 2012-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:34:09

Label at a glance#

ProductSolar Protection Formula SPF 65 Sunscreen

Active ingredientOctinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide

Label structure9 sections

Indications and uses

Helps prevent sunburn. If 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. Use a water resistant product 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 includ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If 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 - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product, keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SHAKE WELL BEFORE USING

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun
May stain some fabrics

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.
Use a water resistant product 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 10:00 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA

Principal Display Panel – 2 oz Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58892-265-59

SOLAR

PROTECTION

FORMULA^®

Oil Free

Non-comedogenic

SPF 65

Broad Spectrum

UVA/UVB

2 Fl. Oz. / 58.8ml

Principal Display Panel – 2 oz Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-265-59	2019-11-27	C162847	48780-1	9855d018-ee3d-cd31-e053-dbdaa90ab51a	b2f7624f-a5ca-42b3-88eb-1af10be4f291

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-265-59	Solar Protection Formula SPF 65 Sunscreen	58.8 mL in 1 BOTTLE	LOTION	58.8		1
58892-265-59	Solar Protection Formula SPF 65 Sunscreen	1 in 1 CARTON	LOTION	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-265	SOLAR PROTECTION FORMULA SPF 65 SUNSCREEN (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [FALLIEN COSMECEUTICALS, LTD.]	1	Legacy NDC, 2 package rows	20130103_b2f7624f-a5ca-42b3-88eb-1af10be4f291.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	1
Octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	1
Octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
.Beta.-Carotene	INACTIVE INGREDIENT	01YAE03M7J	1
5-Bromo-5-Nitro-1,3-Dioxane	INACTIVE INGREDIENT	U184I9QBNM	1
Alkyl (C12-15) Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	1
Aluminum Starch Octenylsuccinate	INACTIVE INGREDIENT	I9PJ0O6294	1
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	1
Butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	1
Cetearyl Glucoside	INACTIVE INGREDIENT	09FUA47KNA	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	1
Isobutylparaben	INACTIVE INGREDIENT	0QQJ25X58G	1
Isopropylparaben	INACTIVE INGREDIENT	A6EOX47QK0	1
Linoleamidopropyl Dimethylamine	INACTIVE INGREDIENT	W142CF4WLF	1
Maritime Pine	INACTIVE INGREDIENT	50JZ5Z98QY	1
Octyldodecyl Neopentanoate	INACTIVE INGREDIENT	X8725R883T	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sorbitan Monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
Tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	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 · 32 matching rows.

Solar Protection Formula SPF 65 Sunscreen
Octinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide
Octinoxate
Octocrylene
Oxybenzone
Titanium Dioxide
Zinc Oxide
Alkyl (C12-15) Benzoate
Aluminum Starch Octenylsuccinate
Ascorbyl Palmitate
5-Bromo-5-Nitro-1,3-Dioxane
.Beta.-Carotene
Butylparaben
Cetostearyl Alcohol
Cetearyl Glucoside
Dimethicone
Edetate Disodium
Ferric Oxide Red
Isobutylparaben
Isopropylparaben
Linoleamidopropyl Dimethylamine
Octyldodecyl Neopentanoate
Phenoxyethanol
Maritime Pine
Polysorbate 20
Propylene Glycol
Sorbitan Monolaurate
Talc
Tocopherol
.Alpha.-Tocopherol Acetate
Triethoxycaprylylsilane
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58892-265	58892-265-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Octinoxate	4Y5P7MUD51	ACTIB
Octocrylene	5A68WGF6WM	ACTIB
Oxybenzone	95OOS7VE0Y	ACTIB
Titanium Dioxide	15FIX9V2JP	ACTIB
Zinc Oxide	SOI2LOH54Z	ACTIB
Alkyl (C12-15) Benzoate	A9EJ3J61HQ	IACT
Aluminum Starch Octenylsuccinate	I9PJ0O6294	IACT
Ascorbyl Palmitate	QN83US2B0N	IACT
5-Bromo-5-Nitro-1,3-Dioxane	U184I9QBNM	IACT
.Beta.-Carotene	01YAE03M7J	IACT
Butylparaben	3QPI1U3FV8	IACT
Cetostearyl Alcohol	2DMT128M1S	IACT
Cetearyl Glucoside	09FUA47KNA	IACT
Dimethicone	92RU3N3Y1O	IACT
Edetate Disodium	7FLD91C86K	IACT
Ferric Oxide Red	1K09F3G675	IACT
Isobutylparaben	0QQJ25X58G	IACT
Isopropylparaben	A6EOX47QK0	IACT
Linoleamidopropyl Dimethylamine	W142CF4WLF	IACT
Octyldodecyl Neopentanoate	X8725R883T	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Maritime Pine	50JZ5Z98QY	IACT
Polysorbate 20	7T1F30V5YH	IACT
Propylene Glycol	6DC9Q167V3	IACT
Sorbitan Monolaurate	6W9PS8B71J	IACT
Talc	7SEV7J4R1U	IACT
Tocopherol	R0ZB2556P8	IACT
.Alpha.-Tocopherol Acetate	9E8X80D2L0	IACT
Triethoxycaprylylsilane	LDC331P08E	IACT
Water	059QF0KO0R	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 · 301 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, EXTENDED RELEASE / ORAL		5119 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
.Beta.-Carotene	BETA CAROTENE	01YAE03M7J	CREAM / TOPICAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 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
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitan Monolaurate	SORBITAN MONOLAURATE	6W9PS8B71J	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		15 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Tocopherol	TOCOPHEROL	R0ZB2556P8	TABLET / ORAL	0.08 mg		Exact identifier — unii candidate 5 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	DROPS / ORAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
Cetostearyl Alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	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
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitan Monolaurate	SORBITAN MONOLAURATE	6W9PS8B71J	AEROSOL, FOAM / TOPICAL		341 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Butylparaben	BUTYLPARABEN	3QPI1U3FV8	TABLET / ORAL	NA		Exact identifier — unii candidate 15 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
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Talc	TALC	7SEV7J4R1U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		60 mg	Exact identifier — unii candidate 35 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

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
0c5df784-589a-48e8-a719-f8e79609215b			b2f7624f-a5ca-42b3-88eb-1af10be4f291	2012-12-27	Warnings	Exact identifier spl id: 0c5df784-589a-48e8-a719-f8e79609215b spl set id: b2f7624f-a5ca-42b3-88eb-1af10be4f291

Reported adverse events (FAERS/openFDA)#

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