Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 52W

Manufacturer
Rare Beauty, LLC
Effective date
2024-10-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:29:11

Label at a glance#

ProductPositive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 54N
Active ingredientTITANIUM DIOXIDE, HOMOSALATE, ZINC OXIDE
Label structure17 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Children under 6 months of age: 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 a.m. - 2 p.m. wear lo...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 9.0%

Titanium Dioxide 1.8%

Zinc Oxide 0.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use if irritation occurs

OTC - STOP USE SECTION

and ask a doctor if a rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: 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 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Dimethicone, Talc, C12-15 Alkyl Benzoate, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Phenoxyethanol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Sodium Dehydroacetate, Hydrogen Dimethicone, Potassium Sorbate, Disteardimonium Hectorite, Lecithin, Benzoic Acid, Aluminum Hydroxide, Alumina, Dehydroacetic Acid, Propylene Carbonate, Helianthus Annuus (Sunflower) Seed Oil, Triethoxycaprylylsilane, Tocopherol, Ethylhexylglycerin, Ascorbyl Palmitate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

Questions?

OTC - QUESTIONS SECTION

Call 1-888-892-7273

Monday-Friday, 7am-4pm PST

Company Information

SPL UNCLASSIFIED SECTION

Dist. By Rare Beauty, LLC

El Segundo, CA 90245

Made in Italy

www.rarebeauty.com

44N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

44N44N

46C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

46C46C

11

48W

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

48W48W

11

50N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50N50N

11

52W

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

52W52W

11

54N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

54N54N

11

56N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

56N56N

11

58N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

58N58N

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82109-116-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N30 mL in 1 BOTTLE, PLASTICLOTION304
82109-116-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N1 in 1 CARTONLOTION14
82109-117-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 46C30 mL in 1 BOTTLE, PLASTICLOTION304
82109-117-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 46C1 in 1 CARTONLOTION14
82109-118-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 48W1 in 1 CARTONLOTION14
82109-118-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 48W30 mL in 1 BOTTLE, PLASTICLOTION304
82109-119-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 50N1 in 1 CARTONLOTION14
82109-119-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 50N30 mL in 1 BOTTLE, PLASTICLOTION304
82109-120-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 52W30 mL in 1 BOTTLE, PLASTICLOTION304
82109-120-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 52W1 in 1 CARTONLOTION14
82109-121-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 54N30 mL in 1 BOTTLE, PLASTICLOTION304
82109-121-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 54N1 in 1 CARTONLOTION14
82109-122-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 56N1 in 1 CARTONLOTION14
82109-122-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 56N30 mL in 1 BOTTLE, PLASTICLOTION304
82109-123-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N1 in 1 CARTONLOTION14
82109-123-01Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 58N30 mL in 1 BOTTLE, PLASTICLOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82109-116POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-117POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-118POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-119POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-120POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-121POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-122POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip
82109-123POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 54N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 56N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 58N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 44N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 46C (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 48W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 50N (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION POSITIVE LIGHT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN 52W (HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE) LOTION [RARE BEAUTY, LLC]4Current NDC, Legacy NDC, 2 package rows20241025_cffbb6af-5a04-f58a-e053-2995a90a1ae2.zip

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 8 · 304 matching rows.

Source Document#

Source XML

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
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44NHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDERare Beauty, LLCcffbb6af-5a04-f58a-e053-2995a90a1ae22024-10-23WarningsExact identifier
ndc (package): 82109-118-01
ndc (package): 82109-119-01
ndc (package): 82109-116-01
ndc (package): 82109-120-01
ndc (package): 82109-123-01
ndc (package): 82109-122-01
ndc (package): 82109-121-01
ndc (package): 82109-117-01
ndc (product): 82109-122
ndc (product): 82109-117
ndc (product): 82109-120
ndc (product): 82109-119
ndc (product): 82109-116
ndc (product): 82109-118
ndc (product): 82109-121
ndc (product): 82109-123
ndc11 (package): 82109012301
ndc11 (package): 82109011901
ndc11 (package): 82109011701
ndc11 (package): 82109012101
ndc11 (package): 82109012001
ndc11 (package): 82109012201
ndc11 (package): 82109011801
ndc11 (package): 82109011601
spl id: 2529b5cc-266a-54c6-e063-6394a90a120e
spl set id: cffbb6af-5a04-f58a-e053-2995a90a1ae2

Reported adverse events (FAERS/openFDA)#

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