FDA.reportPublic FDA data

Prescribers Choice Dynamic Broad Spectrum

Manufacturer
Prescriber's Choice Inc.
Effective date
2018-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:52

Label at a glance#

ProductPrescribers Choice Dynamic Broad Spectrum
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure10 sections

Indications and uses

Help prevent sunburn.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours. 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 of 15 or higher and other sun protection measures including: L...

Storage and handling

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5, Zinc Oxide 4.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Help prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure. *Reapply: At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours. 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am – 2 pm wear long-sleeve shirts, pants, hats, and sunglasses. *For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed By:
Prescriber's Choice
Pompano Beach, FL 33069

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESCRIBER'S
CHOICE

Dynamic
Broad Spectrum

Sunscreen SPF55
Sun Protection

4 fl oz (120ml)

PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 120 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71876-003-502020-01-31C16284748780-19d75b9d0-8fef-f424-e053-dadaa90a57cePrescriber's Choice Dynamic Broad Spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71876-003-50Prescribers Choice Dynamic Broad Spectrum50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71876-003PRESCRIBERS CHOICE DYNAMIC BROAD SPECTRUM (OCTINOXATE AND ZINC OXIDE) LOTION [PRESCRIBER'S CHOICE INC.]1Legacy NDC, 1 package rows20180925_3e3f9c88-3ae4-4e11-b7e4-ec1c1a9dcb74.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71876-00371876-003-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
OCTYL STEARATE772Y4UFC8BIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CYCLOMETHICONENMQ347994ZIACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-3 OLEATEXRQ165498BIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
HEXYL LAURATE4CG9F9W01QIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
7d162bbc-5617-4560-8e7f-c5480868db623e3f9c88-3ae4-4e11-b7e4-ec1c1a9dcb742018-09-21WarningsExact identifier
spl id: 7d162bbc-5617-4560-8e7f-c5480868db62
spl set id: 3e3f9c88-3ae4-4e11-b7e4-ec1c1a9dcb74

Reported adverse events (FAERS/openFDA)#

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