NDC 53208-515-01 - OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK

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
53208-515
Requested NDC
53208-515-01
Package NDCs from labels
53208-515-01, 53208-515-02
Manufacturer
LG Household and Healthcare, Inc.
Effective date
2011-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactLG Household and Healthcare, Inc.2011-03-28HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53208-515-022019-10-29C16284748780-1960f7f55-c632-8e05-e053-dbdaa90a074aDrug Fact

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-515-01OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK40 g in 1 CONTAINERCREAM401
53208-515-02OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-515OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1Legacy NDC, 2 package rows20110408_adef3aa6-3369-4da2-b7c4-37d80ccdad66.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEACTIVE INGREDIENTANQ870JD20OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W42OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
HYDROXYPROLINEACTIVE INGREDIENTRMB44WO89XOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEACTIVE MOIETYANQ870JD20OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W42OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
HYDROXYPROLINEACTIVE MOIETYRMB44WO89XOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
BIOSACCHARIDE GUM-1INACTIVE INGREDIENTBB4PU4V09HOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX4OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CETYL PHOSPHATEINACTIVE INGREDIENTVT07D6X67OOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0ROHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
INULININACTIVE INGREDIENTJOS53KRJ01OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
ISODODECANEINACTIVE INGREDIENTA8289P68Y2OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE, 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 1 of 403 · 8,054 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERA SILKYSTAY FOUNDATION 37W1TITANIUM DIOXIDEAmorepacific Corporation5f4105f3-d08b-edb5-e063-6394a90ad28b2026-11-01WarningsExact identifier
unii: 15FIX9V2JP
Note Mattifying Extreme Wear Foundation 130 Cool RoseOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIc52d92d9-e228-4840-aacc-ed97a61734432026-10-29WarningsExact identifier
unii: 4Y5P7MUD51
HERA SILKYSTAY FOUNDATION 28O1TITANIUM DIOXIDEAmorepacific Corporation5ec77f7a-4621-ac0c-e063-6294a90a3f702026-10-26WarningsExact identifier
unii: 15FIX9V2JP
RoC Barrier Renew AM Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare020aa79f-4fd6-1ea1-e063-6394a90a44642026-10-14WarningsExact identifier
unii: 4X49Y0596W
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-10-02WarningsExact identifier
unii: 15FIX9V2JP
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC52bbc6cd-4bc2-7859-e063-6394a90ac87d2026-10-01WarningsExact identifier
unii: 4X49Y0596W
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
unii: 4Y5P7MUD51
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
unii: 4Y5P7MUD51
Wet Ones Hand Sanitizer Mist Lavender BlossomETHYL ALCOHOLEdgewell Personal Care Brands LLCdae52e15-9161-c8d2-e053-2a95a90adb982026-09-29WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON HAND SANITIZER Pink Guava SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO0adfe188-4613-47dc-a9a3-5c9cfca781a82026-09-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip cookie scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO69d423f2-ff9f-48e0-a553-c7f4aaf37b292026-09-17WarningsExact identifier
unii: 3K9958V90M
TRILIPIDERM All-Body Moisture Retention SPF-30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENETrilipid Research Institute, LLC7f34de0a-eeb3-4b71-9abd-53d03266d9932026-09-10WarningsExact identifier
unii: 4Y5P7MUD51
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6a43173f-41f9-4207-a0db-53bc8db6f4a42026-09-10WarningsExact identifier
unii: 4X49Y0596W
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd69b4992-d7e6-4bd7-b144-0485e35818a62026-09-10WarningsExact identifier
unii: 4X49Y0596W
Hydra Finish SPF 15HOMOSALATE, OCTINOXATEGuinot4047e8ec-834a-41e6-a144-5649a7718de42026-09-10WarningsExact identifier
unii: 4Y5P7MUD51
HYDRA BEAUTE SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot806d1e18-a3fc-43df-a52a-a640902d08872026-09-10WarningsExact identifier
unii: 4X49Y0596W
unii: 4Y5P7MUD51
Pur Confort SPF 15AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinot2fe0656f-f924-48da-91bf-d6f3d98e8fd92026-09-10WarningsExact identifier
unii: 4X49Y0596W
unii: 4Y5P7MUD51
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC51f3d6ca-3189-4380-9afb-4259ba8782742026-09-10WarningsExact identifier
unii: 4X49Y0596W
Sun Logic Creme Solaire Visage et corps SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEGuinotb0a95379-998a-4cda-bae7-63faf3d6f3c82026-09-10WarningsExact identifier
unii: 4X49Y0596W
unii: 4Y5P7MUD51
SunscreenBROAD SPECTRUM SPF 301226 W AESTHETICS5b0ef395-a7dd-378e-e063-6394a90a5dce2026-09-09WarningsExact identifier
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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