FDA.reportPublic FDA data

Prequel Lip Visor SPF 30 ROSEDUST

Manufacturer
The Center Brands, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:43

Label at a glance#

ProductPrequel Lip Visor SPF 30 ROSEDUST
Active ingredientAVOBENZONE, OCTINOXATE
Label structure10 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

• apply liberally and evenly 15 minutes before sun exposure • reapply: •at least every 2 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octinoxate 7.5%

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
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 docor if rash occurs
Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally and evenly 15 minutes before sun exposure
• reapply: •at least every 2 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

Petrolatum, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilonleate, Diisostearyl Malate, Polybutene, Hydrogenated Polyisobutene, Sorbeth-2 Hexaoleate, Flavor, Ethylhexyl Methoxycrylene, Butyropsermum Parkii Butter, Synthetic Wax, Microcrystalline Wax, Oryzanol, Mica, Helianthus Annuus Seed Oil, Physalis Angulata Extract, Caprylic/Capric Triglyceride, Bisabolol, Siraita Grosvenorii Fruit Extract, Tocopherol, BHT, Citric Acid, Limonene, Linalool, Citral, Citronellol. [+/-: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 19140, CI 42090, CI 17200]

Other Information

SPL UNCLASSIFIED SECTION

• protect the product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

Visit prequelskin.com

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Purpose

OTC - PURPOSE SECTION

Sunscreen

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-07082800-070

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-080-01Prequel Lip Visor SPF 30 ROSEDUST10 mg in 1 TUBELIQUID102
82800-080-01Prequel Lip Visor SPF 30 ROSEDUST1 in 1 PACKAGELIQUID12

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
82800-08082800-080-01

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
DIISOSTEARYL MALATEQBS8A3XZGQIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
HYDROGENATED POLYISOBUTENE (1300 MW)7D1YQ9Y5EZIACT
SORBETH-2 HEXAOLEATEF3ECF77W74IACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
ORYZANOLSST9XCL51MIACT
MICAV8A1AW0880IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PHYSALIS ANGULATA WHOLEW4TKW9D5GGIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BISABOLOL24WE03BX2TIACT
SIRAITIA GROSVENORII FRUITNOU2FB51TWIACT
TOCOPHEROLR0ZB2556P8IACT
BHT1P9D0Z171KIACT
CITRIC ACID2968PHW8QPIACT
LIMONENE, (+/-)-9MC3I34447IACT
LINALOOL, (+/-)-D81QY6I88EIACT
CITRALT7EU0O9VPPIACT
CITRONELLOLP01OUT964KIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BROWN IRON OXIDE1N032N7MFOIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
YELLOW 5I753WB2F1MIACT
RED 7ECW0LZ41X8IACT
RED 339DBA0SBB0LIACT
AVOBENZONEG63QQF2NOXACTIB
PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE8N725H4EFNIACT
PETROLATUM4T6H12BN9UIACT
OCTINOXATE4Y5P7MUD51ACTIB

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
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
ndc (package): 82800-080-01
ndc (product): 82800-080
ndc11 (package): 82800008001
spl id: 45200a46-7577-78f4-e063-6294a90a3580
spl set id: 33d5e1ad-ba7a-25f8-e063-6294a90aa38e

Reported adverse events (FAERS/openFDA)#

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