PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | The Estee Lauder Inc
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:56:45

Label at a glance#

ProductPEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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...

Storage and handling

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

Titanium Dioxide 6.3%
Zinc Oxide 4.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash 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

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • 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
  • children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water\aqua\eau • dimethicone • butyloctyl salicylate • polydiethylsiloxane • c12-15 alkyl benzoate • isononyl isononanoate • diethylhexyl succinate • neopentyl glycol diheptanoate • methyl trimethicone • butylene glycol • ethylhexyl methoxycrylene • lauryl peg-9 polydimethylsiloxyethyl ethylhexyl dimethicone • silica • laureth-4 • cetyl peg/ppg-10/1 dimethicone • dipentaerythrityl tri-polyhydroxystearate • hydrolyzed wheat protein/pvp crosspolymer • caprylyl glycol • dimethicone silylate • dimethicone/peg-10/15 crosspolymer • isostearic acid • dimethicone crosspolymer-3 • polyhydroxystearic acid • triethoxycaprylylsilane • dipropylene glycol • phenoxyethanol • iron oxides (ci 77491) • iron oxides (ci 77492) [iln43311]

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE

pep-start

daily UV protector
broad spectrum
SPF 50

1 FL.OZ.LIQ./30 ml e

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-073-01PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 5030 mL in 1 BOTTLELOTION309
49527-073-01PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 501 in 1 CARTONLOTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-073PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES LLC]9Current NDC, Legacy NDC, 2 package rows20231014_68cfcbc2-a214-437e-9956-f77c90d74888.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-07349527-073-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC68cfcbc2-a214-437e-9956-f77c90d748882023-10-13WarningsExact identifier
ndc (package): 49527-073-01
ndc (product): 49527-073
ndc11 (package): 49527007301
spl id: 079bb7e2-552c-cf0e-e063-6394a90a74c8
spl set id: 68cfcbc2-a214-437e-9956-f77c90d74888

Reported adverse events (FAERS/openFDA)#

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