FDA.reportPublic FDA data

Paulas Choice Ultra Sheer Daily Defense SPF 30

Manufacturer
Paula's Choice, LLC.
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:18:50

Label at a glance#

ProductPaulas Choice Ultra Sheer Daily Defense SPF 30
Active ingredientAVOBENZONE, OXYBENZONE, OCTOCRYLENE, HOMOSALATE
Label structure8 sections

Indications and uses

Helps prevent sunburn Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures

Dosage and administration

apply liberally 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating. reapply at least every two hours if skin is exposed to sun Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and and early skin aging. To decrease this resk regulatly use a sunscreen with a broad-spectrum SPF of 15 or greater and other sun protection measures including: Limit ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 7.0%

Octocrylene 2.0%

Oxybenzone 4.0%

OTC - PURPOSE SECTION

Moisturizer and sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • Decreases the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures

Directions

INDICATIONS & USAGE SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water-resistant sunscreen if swimming or sweating.
  • reapply at least every two hours if skin is exposed to sun
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and and early skin aging. To decrease this resk regulatly use a sunscreen with a broad-spectrum SPF of 15 or greater and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. wear a long sleep shirt, pants, sunglasses, and hat. Children under 6 months: Ask a doctor

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

on damaged or broken skin

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

If rash occurs. If product is swallowed, get medical help or contact a Poison Control Center right away

OTC - STOP USE SECTION

If rash occurs

Other Information

OTHER SAFETY INFORMATION

  • protect this product from excessive heat and direct sun
  • you may report serious and adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057

Inactive Ingredient Section

Water

Butylene Glycol

Silica

Camellia Sinensis Leaf Extract

Aloe Barbadensis Leaf Juice Powder

Ascorbyl Palmitate

Phospholipids

Superoxide Dismutase

Adenosine

Tocopherol

Bisabolol

Boerhavia Diffusa Root Extract

Colloidal Oatmeal

Panthenol

Ginkgo Biloba Leaf Extract

Salix Alba (Willow) Bark Extract

Cetyl Dimethicone

Aluminum Starch Octenylsuccinate

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Titanium Dioxide

Sorbic Acid

Sodium Hydroxide

Steareth-21

Steareth-2

Polysorbate 20

Disodium EDTA

Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Component LabelComponent Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76144-156-002020-01-31C16284748780-19d75b9cf-edc2-f424-e053-dadaa90a57cePaula's Choice Ultra-Sheer Daily Defense SPF 30

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76144-15676144-156-01, 76144-156-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINEK72T3FS567IACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
STEARETH-2V56DFE46J5IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GINKGO19FUJ2C58TIACT
EDETATE DISODIUM7FLD91C86KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
PHENOXYETHANOLHIE492ZZ3TIACT
OATMEAL8PI54V663YIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYSORBATE 207T1F30V5YHIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
SORBIC ACIDX045WJ989BIACT
SODIUM HYDROXIDE55X04QC32IIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BOERHAVIA DIFFUSA ROOTKR0SR09KYLIACT
SALIX ALBA BARK205MXS71H7IACT
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)W2T4YRA9ADIACT
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB

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
c54ddd72-5d71-218c-e053-2995a90a7cee1318c6e0-aa3d-5968-e054-00144ff8d46c2022-01-06WarningsExact identifier
spl id: c54ddd72-5d71-218c-e053-2995a90a7cee
spl set id: 1318c6e0-aa3d-5968-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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