PL-1849

Manufacturer
Broder Bros Co., | Prime Resources Corp | Yuyao Jessie Commodity Co., Ltd.
Effective date
2019-09-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:13:10

Label at a glance#

ProductPL-1849
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, OXYBENZONE
Label structure8 sections

Dosage and administration

Apply liberally for 15 minutes before sun exposure and as needed Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

PL-1849 Back LabelPL-1849 Back LabelOctinoxate(7%)

Octisalate(4%)

Oxybenzone(3%)

Titanium dioxide(4%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS AND PRECAUTIONS SECTION

Skin Cancer/Skin Aging Alert; Spending time in the sun increases

your risk of skin cancer and early skin aging. This product has been

shown only to help prevent sunburn, not skin cancer or early skin aging.

Warnings

WARNINGS SECTION

For external use only.

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

Warnings

OTC - STOP USE SECTION

Stop use & ask a doctor if rash occurs.

Warnings

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally for 15 minutes before sun exposure and as needed
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

C12-15 Alkyl Benzoate, Isopropyl Myristate, Caprylic/Capric Triglyceride, Cetearyl Alcohol,

Ceteth-25, Glyceryl Stearate, Glycerin, DMDM Hydantoin, Metyl Paraben, Proplyparaben,

Fragance, Water(Aqua)

Questions?

OTC - QUESTIONS SECTION

1-800-873-7746 M-F 8am-5pm EST

OTHER SAFETY INFORMATION

Lot no:

Use by:

Made in China

Distributed by: Prime Resource Corp Bridgeport, CT 06610

Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL-1849 Front LabelPL-1849 Front LabelSunscreen

SPF 30

1 FL OZ (29.5mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71513-849-012022-11-28C16284748780-1c7ccaba7-0eb5-fd44-e053-dadaa90aa01b551614f2-e3e0-1186-e054-00144ff88e88
71513-849-012021-07-23C16284748780-1c7ccaba7-0eb5-fd44-e053-dadaa90aa01b551614f2-e3e0-1186-e054-00144ff88e88

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71513-84971513-849-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
ee8c341f-3df7-9af1-e053-2995a90ae55a551614f2-e3e0-1186-e054-00144ff88e882022-11-28WarningsExact identifier
spl set id: 551614f2-e3e0-1186-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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