NDC 67938-2003-2 - VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 67938-2003
Requested NDC: 67938-2003-2
Package NDCs from labels: 67938-2003-2, 67938-2003-1
Manufacturer: Elizabeth Arden, Inc
Effective date: 2013-07-31
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, and OXYBENZONE - Elizabeth Arden, Inc	Elizabeth Arden, Inc	2013-07-31	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67938-2003-1	2019-11-27	C162847	48780-1	9855d018-ea11-cd31-e053-dbdaa90ab51a	222614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67938-2003-1	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2	1 in 1 BOX	CREAM	1		1
67938-2003-2	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2	34 g in 1 BOTTLE	CREAM	34		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67938-2003	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1	Legacy NDC, 2 package rows	20130801_d89ef224-6bd2-4205-87bd-483092f79fe1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
ADENOSINE	INACTIVE INGREDIENT	K72T3FS567	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
BUTYLPHENYL METHYLPROPIONAL	INACTIVE INGREDIENT	T7540GJV69	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
C20-40 PARETH-3	INACTIVE INGREDIENT	68103A23TQ	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
DECYLENE GLYCOL	INACTIVE INGREDIENT	S57M60MI88	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
GERANIOL	INACTIVE INGREDIENT	L837108USY	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)	INACTIVE INGREDIENT	86FQE96TZ4	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
ISOHEXADECANE	INACTIVE INGREDIENT	918X1OUF1E	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
PEG-10 DIMETHICONE (600 CST)	INACTIVE INGREDIENT	8PR7V1SVM0	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
PEG-8 DIMETHICONE	INACTIVE INGREDIENT	GIA7T764OD	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
STEARETH-2	INACTIVE INGREDIENT	V56DFE46J5	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
STEARETH-21	INACTIVE INGREDIENT	53J3F32P58	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	VISIBLE DIFFERENCE MULTI TARGETED BB CREAM BROAD SPECTRUM SUNSCREEN SPF 30 SHADE 2 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, AND OXYBENZONE) CREAM [ELIZABETH ARDEN, INC]	1

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 174 of 311 · 6,216 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	055431a6-e9e0-99b4-e063-6394a90acb11	2025-04-17	Warnings	Exact identifier unii: 4X49Y0596W
SILKEN pore perfecting sunscreen broad spectrum SPF 35	OCTISALATE, ZINC OXIDE	TATCHA INC.	251566a1-0e21-4030-9d4e-52c4a8bd3330	2025-04-16	Warnings	Exact identifier unii: 4X49Y0596W
Sunscreen Lip Balm SPF 30 Cool Mint	AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%	USRX	3271ab14-3bf5-a24f-e063-6294a90a59bc	2025-04-16	Warnings	Exact identifier unii: 4X49Y0596W
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	CLIO COSMETICS Co., Ltd.	77a0d190-f558-474b-89d2-c79b37c50c0d	2025-04-16	Warnings	Exact identifier unii: 4X49Y0596W
DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE	KOS America, Inc.	2b41c17d-1394-0c2f-e063-6394a90a0c49	2025-04-15	Warnings	Exact identifier unii: 4X49Y0596W unii: 4Y5P7MUD51
Urban Antioxidant Sunscreen SPF 40	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM	Dr. Loretta, LLC	930150a3-08bb-17fd-e053-2995a90a786b	2025-04-15	Warnings	Exact identifier unii: 4X49Y0596W
Adenosine	ADENOSINE	Meitheal Pharmaceuticals Inc.	b6851256-6cef-4f23-8129-19bb64380cd5	2025-04-14	Warnings, Adverse reactions	Exact identifier unii: K72T3FS567
Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Have & Be Co., Ltd.	32c1aba6-5e29-aba9-e063-6394a90a8e56	2025-04-14	Warnings	Exact identifier unii: 15FIX9V2JP
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	07701e11-8a7e-44c5-b46e-5b48264eacad	2025-04-14	Warnings	Exact identifier unii: 15FIX9V2JP unii: 4X49Y0596W unii: 4Y5P7MUD51
Gas Relief - Cherry Flavor	SIMETHICONE	TARGET CORPORATION	290fe08d-a0b9-82f7-e063-6394a90a9c75	2025-04-11	Warnings	Exact identifier unii: 92RU3N3Y1O
No7 Protect and Perfect Intense Advanced Day Cream SPF 30	AVOBENZONE,OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3285e28d-5716-b576-e063-6294a90a8905	2025-04-11	Warnings	Exact identifier unii: 4X49Y0596W
No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30	AVOBENZONE,OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32876315-f81f-fdd2-e063-6394a90ad5f7	2025-04-11	Warnings	Exact identifier unii: 4X49Y0596W
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3287ae2e-759e-31c5-e063-6394a90a892f	2025-04-11	Warnings	Exact identifier unii: 4X49Y0596W unii: 4Y5P7MUD51
Infants	SIMETHICONE	ATLANTIC BIOLOGICALS CORP.	27fce442-e328-41d2-bab9-87ab21550c04	2025-04-11	Warnings	Exact identifier unii: 92RU3N3Y1O
No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	32b5a19e-86d4-5ee1-e063-6394a90a12e2	2025-04-11	Warnings	Exact identifier unii: 4X49Y0596W
Rolaids Advanced Antacid Anti-gas Mixed Berry	CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONE	Chattem, Inc.	3884c05a-a593-424e-88b3-be962e73488e	2025-04-10	Warnings	Exact identifier unii: 92RU3N3Y1O
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ENGLEWOOD LAB, INC.	edf07b7f-46fb-4915-b2ea-83d852617f60	2025-04-10	Warnings	Exact identifier unii: 4X49Y0596W
Smoothing Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DANIEL BEHROOZAN MD A MEDICAL CORPORATION	327246c2-9d7a-2d34-e063-6294a90a5fb7	2025-04-10		Exact identifier unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	b5111012-97b9-4908-95a0-d09595f9c4d9	2025-04-10	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Topiderm, Inc.	13e5085f-df2b-46b2-b063-e58ce4379905	2025-04-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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