Light CC creme Broad Spectrum SPF 15

Manufacturer: Jafra Cosmetics International | Jafra Manufacturing, S.A. de C.V
Effective date: 2019-05-14
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:59:28

Label at a glance#

ProductLight CC creme Broad Spectrum SPF 15 JAFRA

Active ingredientZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active

ingredients Purpose

Zinc Oxide 6.8% ......... Sunscreen

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming of 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, regularyl use a sunscreen with a Broad Spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Water/Aqua, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Cyclomethicone, Caprylic Capric Triglyceride, Polyhyroxystearic Acid, Propanediol, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Iron Oxides/ CI 77491/CI 77492/CI 77499, Methicone, Glycerin, Sodium Chloride, Sodium Dehydroacetate, DMDM Hydantoin, Palmitic Acid, Disodium EDTA, Dextrin, Palmitate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cucumis Sativus Extract, Glycrrhiza Glabra Extract, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Light

Jafra

CC Creme

Broad Spectrum SPF 15

30 ml / 1 FL OZ (US)

Box

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68828-235-02	2022-01-28	C162847	48780-1	d6a99b39-9e9d-a426-e053-dadaa90af4c2	CC Creme Broad Spectrum SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68828-235-01	Light CC creme Broad Spectrum SPF 15JAFRA	30 mL in 1 TUBE	CREAM	30		4
68828-235-02	Light CC creme Broad Spectrum SPF 15JAFRA	1 in 1 BOX	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68828-235	LIGHT CC CREME BROAD SPECTRUM SPF 15 JAFRA (ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]	4	Legacy NDC, 2 package rows	20190515_4a0a8542-4916-4562-829a-0d886f152fa8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
BORON NITRIDE	INACTIVE INGREDIENT	2U4T60A6YD	1
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DISTEARDIMONIUM HECTORITE	INACTIVE INGREDIENT	X687XDK09L	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	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
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	1
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	1
METHICONE (20 CST)	INACTIVE INGREDIENT	6777U11MKT	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	1
PEG-10 DIMETHICONE (600 CST)	INACTIVE INGREDIENT	8PR7V1SVM0	1
PEG-4 LAURATE	INACTIVE INGREDIENT	AYF4VM3N1Z	1
PEG/PPG-18/18 DIMETHICONE	INACTIVE INGREDIENT	9H0AO7T794	1
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	1
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	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 · 31 matching rows.

Light CC creme Broad Spectrum SPF 15 JAFRA
Zinc Oxide
ZINC CATION
WATER
CYCLOMETHICONE 5
PEG/PPG-18/18 DIMETHICONE
CYCLOMETHICONE
MEDIUM-CHAIN TRIGLYCERIDES
POLYHYDROXYSTEARIC ACID (2300 MW)
PROPANEDIOL
TITANIUM DIOXIDE
TRIETHOXYCAPRYLYLSILANE
DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
DISTEARDIMONIUM HECTORITE
BORON NITRIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
METHICONE (20 CST)
GLYCERIN
SODIUM CHLORIDE
SODIUM DEHYDROACETATE
DMDM HYDANTOIN
PALMITIC ACID
EDETATE DISODIUM
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
CUCUMBER
GLYCYRRHIZA GLABRA
TOCOPHEROL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68828-235	68828-235-01, 68828-235-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIM
WATER	059QF0KO0R	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
PEG/PPG-18/18 DIMETHICONE	9H0AO7T794	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
POLYHYDROXYSTEARIC ACID (2300 MW)	YXH47AOU0F	IACT
PROPANEDIOL	5965N8W85T	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
DIMETHICONE	92RU3N3Y1O	IACT
PEG-10 DIMETHICONE (600 CST)	8PR7V1SVM0	IACT
DISTEARDIMONIUM HECTORITE	X687XDK09L	IACT
BORON NITRIDE	2U4T60A6YD	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
METHICONE (20 CST)	6777U11MKT	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
PALMITIC ACID	2V16EO95H1	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PEG-4 LAURATE	AYF4VM3N1Z	IACT
IODOPROPYNYL BUTYLCARBAMATE	603P14DHEB	IACT
CUCUMBER	YY7C30VXJT	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
TOCOPHEROL	R0ZB2556P8	IACT

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 7 · 413 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 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
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY, METERED / SUBLINGUAL		110 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET / ORAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 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
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	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PEG/PPG-18/18 DIMETHICONE	PEG/PPG-18/18 DIMETHICONE	9H0AO7T794	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	CAPSULE / ORAL		4771 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 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 / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAVITARY	0.82 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBMUCOSAL	16 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 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
a5d69dc9-8b1a-4a8b-9e03-25274209a795			4a0a8542-4916-4562-829a-0d886f152fa8	2019-05-14	Warnings	Exact identifier spl id: a5d69dc9-8b1a-4a8b-9e03-25274209a795 spl set id: 4a0a8542-4916-4562-829a-0d886f152fa8

Reported adverse events (FAERS/openFDA)#

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