FDA.reportPublic FDA data

Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50

Manufacturer
The Center Brands, LLC
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:07

Label at a glance#

ProductPrequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE
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 generously 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 su...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

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. If swalled, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply generously 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

Water (Aqua), Caprylic/Capric Triglyceride, Diisooctyl Succinate, Butyloctyl Salicylate, Propanediol, Glycerin, Cetearyl Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Polyhydroxystearic Acid, Sorbitan Olivate, Bisabolol, Pongamia Pinnata Seed Extract, Zingiber Officinale Root Extract, Tetrahydrodiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Tetrahydrodemethoxydiferuloylmethane, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Centella Asiatica Extract, Phenoxyethanol, Polyglyceryl-4 Laurate/Succinate, Lauroyl Lysine, Triethoxycaprylylsilane, Arachidyl Alcohol, Silica, Xanthan Gum, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Glycol, VP/Eicosene Copolymer, Arachidyl Glucoside, Tetrasodium Glutamate Diacetate, Ethylhexylglycerin, Tocopheryl Acetate, Cetyl Alcohol, Tin Oxide, Isononyl Isononanoate, Ethylene/Propylene/Styrene Copolymer, Soribitan Oleate, Titanium Dioxide (CI 77891), Mica (CI 77019), Iron Oxides (CI 77499, CI 77491)

Other Information

SPL UNCLASSIFIED SECTION

• protect the product in this container 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

Prupose

OTC - PURPOSE SECTION

Sunscreen

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-010-0182800-010-01

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82800-010-01Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 5050 g in 1 TUBECREAM503
82800-010-01Prequel Sun Barrier Mineral Sunscreen Broad Spectrum SPF 501 in 1 PACKAGECREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82800-010PREQUEL SUN BARRIER MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (MINERAL SUNSCREEN) CREAM [THE CENTER BRANDS, LLC]3Current NDC, 2 package rows20250119_cd35ae20-d5b7-479d-8a5e-0278eae9e83c.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-01082800-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIISOCETYL ADIPATE14885YC9LUIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
CETEARYL OLIVATE58B69Q84JOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SORBITAN OLIVATEMDL271E3GRIACT
.BETA.-BISABOLOLLP618AV2EAIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
ZINGIBER OFFICINALE WHOLEIN6Q3S3414IACT
TETRAHYDRODIFERULOYLMETHANE00U0645U03IACT
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE44D8X9U00TIACT
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE973IBV8W7IIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAMELLIA SINENSIS SEEDMRL49Z8AC4IACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
CENTELLA ASIATICA7M867G6T1UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 LAURATE/SUCCINATEKAB6DS9SBSIACT
LAUROYL LYSINE113171Q70BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SILICONZ4152N8IUIIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETYL ALCOHOL936JST6JCNIACT
STANNIC OXIDEKM7N50LOS6IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MICAV8A1AW0880IACT
BROWN IRON OXIDE1N032N7MFOIACT
ZINC OXIDESOI2LOH54ZACTIM

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 Sun Barrier Mineral Sunscreen Broad Spectrum SPF 50MINERAL SUNSCREENThe Center Brands, LLCcd35ae20-d5b7-479d-8a5e-0278eae9e83c2025-01-17WarningsExact identifier
ndc (package): 82800-010-01
ndc (product): 82800-010
ndc11 (package): 82800001001
spl id: 2bf08ea6-beb4-7556-e063-6394a90a01d9
spl set id: cd35ae20-d5b7-479d-8a5e-0278eae9e83c

Reported adverse events (FAERS/openFDA)#

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