FDA.reportPublic FDA data

Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen

Manufacturer
Emilia Personal Care Inc.
Effective date
2013-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:04

Label at a glance#

ProductSafe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protections 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 Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor Sun Protection Measures : Spending time in the sun increases your risk of sun 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 12.35%
Zinc Oxide 3.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • if 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 2 hours
  • Use water resistant sunscreen if swimming or sweating
  • Children under 6 months: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

SPL UNCLASSIFIED SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, caprylic/capric triglyceride, C12-15 alkyl benzoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, trimethoxycaprylylsilane, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), butyrospermum parkii (shea butter), persea gratissima (avocado) oil, cananga odorata (ylang-ylang) flower oil, pelargonium graveolens (geranium) flower oil, citrus aurantium bergamia (bergamot) fruit oil, citrus aurantium dulcis (orange) oil, citrus medica limonum (lemon) peel oil, cymbopogon martini (palmarosa) oil, ellettaria cardamomum (cardamon) seed oil, aloe barbadensis leaf juice, allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, astaxanthin, bisabolol, hippophae rhamnoides oil, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safe Harbor™ Natural Suncare

Free from chemical UV filters

40 Mineral SPF Broad Spectrum Sunscreen

Face & Neck Cream
With Natural Anti-Aging Complex

Moisturizing sunscreen

Anti-aging treatment
rich in age-defying antioxidants

3 Fl. Oz (88.7 mL)

Distributed by: Emilia Personal Care.
Manufactured in Israel.
For more information visit: www.safeharborsuncare.com

UVA, UVB
With Certified Organic Ingredients
Water Resistant
Allergy Tested

ZX41 2E T1

Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42421-418-112020-01-31C16284748780-19d75b9d0-e13d-f424-e053-dadaa90a57ceSafe Harbor Natural Suncare

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42421-418-11Safe Harbor - Natural Sunscreen Face and Neck Cream Broad Spectrum SPF40 Sunscreen88.7 mL in 1 TUBECREAM88.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42421-418SAFE HARBOR - NATURAL SUNSCREEN FACE AND NECK CREAM BROAD SPECTRUM SPF40 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA PERSONAL CARE INC.]1Legacy NDC, 1 package rows20140105_9e2fb9bb-8a79-4675-84df-fd5990f7db1d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ASPALATHUS LINEARIS LEAFINACTIVE INGREDIENTH7UGK1GJCU1
ASTAXANTHININACTIVE INGREDIENT8XPW32PR7I1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
BERGAMOT OILINACTIVE INGREDIENT39W1PKE3JI1
CANANGA OILINACTIVE INGREDIENT8YOY78GNNX1
CARDAMOMINACTIVE INGREDIENT8BC4CUT4JL1
CETYL DIMETHICONE 150INACTIVE INGREDIENT5L694Y0T221
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0X1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HIPPOPHAE RHAMNOIDES FRUIT OILINACTIVE INGREDIENTTA4JCF9S1J1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
LEMON OILINACTIVE INGREDIENTI9GRO824LL1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92191
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
ORANGE OILINACTIVE INGREDIENTAKN3KSD11B1
PALMAROSA OILINACTIVE INGREDIENT0J3G3O53ST1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
PELARGONIUM GRAVEOLENS FLOWER OILINACTIVE INGREDIENT3K0J1S7QGC1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SHEANUT OILINACTIVE INGREDIENTO88E196QRF1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SOY ISOFLAVONESINACTIVE INGREDIENT71B37NR06D1
TILIA X EUROPAEA FLOWERINACTIVE INGREDIENTNHV2K1OUDH1
TRICAPRYLININACTIVE INGREDIENT6P928589881
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-41842421-418-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TRICAPRYLIN6P92858988IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIMETHOXYCAPRYLYLSILANEFZ07E4LW2MIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SHEANUT OILO88E196QRFIACT
AVOCADO OIL6VNO72PFC1IACT
CANANGA OIL8YOY78GNNXIACT
PELARGONIUM GRAVEOLENS FLOWER OIL3K0J1S7QGCIACT
BERGAMOT OIL39W1PKE3JIIACT
ORANGE OILAKN3KSD11BIACT
LEMON OILI9GRO824LLIACT
PALMAROSA OIL0J3G3O53STIACT
CARDAMOM8BC4CUT4JLIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
PANTHENOLWV9CM0O67ZIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
SOY ISOFLAVONES71B37NR06DIACT
POLYSORBATE 806OZP39ZG8HIACT
ASTAXANTHIN8XPW32PR7IIACT
LEVOMENOL24WE03BX2TIACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
CHAMOMILEFGL3685T2XIACT
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT

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 · 335 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRASYNOVIAL0.2 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HAEROSOL, FOAM / TOPICAL0.98 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BSUSPENSION / ORAL1 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGRANULE, FOR SUSPENSION / ORAL240 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS4739 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / INTRAVENOUS900 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRALESIONAL4 mgExact identifier — unii candidate
78 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BELIXIR / ORAL0.24 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSPRAY / NASAL0.01 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS53 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates
ORANGE OILORANGE OIL, COLD PRESSEDAKN3KSD11BTABLET, CHEWABLE / ORAL3.7 mgExact identifier — unii candidate
6 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, DELAYED RELEASE / ORAL1337 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.68 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGEL / TOPICAL12 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / EPIDURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYSTEM / IONTOPHORESIS3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SOLUTION / INTRAMUSCULAR5 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9e2fb9bb-8a79-4675-84df-fd5990f7db1d9e2fb9bb-8a79-4675-84df-fd5990f7db1d2013-11-19WarningsExact identifier
spl id: 9e2fb9bb-8a79-4675-84df-fd5990f7db1d
spl set id: 9e2fb9bb-8a79-4675-84df-fd5990f7db1d

Reported adverse events (FAERS/openFDA)#

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