FDA.reportPublic FDA data

Paulas Choice

Manufacturer
Prime Enterprises
Effective date
2024-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:01:03

Label at a glance#

ProductPaulas Choice Broad Spectrum SPF 50
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and uses

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

Dosage and administration

SHAKE WELL. Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply: immediately after towel drying at least every two hours 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 of 15 or h...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

  • SHAKE WELL. Apply liberally 15 minutes before sun exposure
  • Use a water-resistant sunscreen if swimming or sweating
  • Reapply:
  • immediately after towel drying
  • at least every two hours
  • 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 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

Other Information

OTHER SAFETY INFORMATION

protect the product in this container from excessive heat and direct sun. Store at 20 - 25 °C (68 - 77 °F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Silica, 3-O-Ethyl Ascorbic Acid, Ascorbyl Glucoside, Dimethicone, Propanediol, Tetrahexyldecyl Ascorbate, Acetyl Zingerone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Diethylhexyl Syringylidenemalonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Entada Phaseoloides Bark/Seed Extract, Porphyra Umbilicalis Extract, Hydrogenated Lecithin, Ricinus Communis (Castor) Seed Oil, Sodium Hydroxide, Tocopherol, Xanthan Gum, Ethylhexylglycerin, Laureth-4, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Titanium Dioxide, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1.800.831.4088 (U.S. and Canada) Mon-Fri 6 am - 6 pm PT | Sat-Sun 8 am - 4:30 pm PT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-066058443-0660-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM BENZOATEOJ245FE5EUIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
XANTHAN GUMTTV12P4NEEIACT
LAURETH-46HQ855798JIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
BROWN IRON OXIDE1N032N7MFOIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ACETYL ZINGERONEV9D92S9YE5IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
ENTADA PHASEOLOIDES SEED4R80X8KTM7IACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PROPANEDIOL5965N8W85TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
FERRIC OXIDE RED1K09F3G675IACT
WATER059QF0KO0RIACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
1a153e2a-85bd-68ac-e063-6394a90aa1331a152fbb-bdca-8d46-e063-6394a90ad9062024-06-04WarningsExact identifier
spl id: 1a153e2a-85bd-68ac-e063-6394a90aa133
spl set id: 1a152fbb-bdca-8d46-e063-6394a90ad906

Reported adverse events (FAERS/openFDA)#

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