FDA.reportPublic FDA data

Pyratine XR Creme With Sunscreen Broad Spectrum SPF30

Manufacturer
Allure Labs Inc
Effective date
2017-12-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:21

Label at a glance#

ProductPyratine XR Creme With Sunscreen Broad Spectrum SPF30
Active ingredientZINC OXIDE
Label structure13 sections

Storage and handling

Store at controlled room temperature 59 F - 89 F (15 C - 30 C).

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Zinc oxide - 18.6%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against 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 SECTION

Warnings: For external use only. 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 or irritation developes and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Cpntrol center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • For sunscreen use. 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Call toll free 1-888-467-9728

STORAGE AND HANDLING SECTION

Store at controlled room temperature 59 F - 89 F (15 C - 30 C).

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Developed, Distributed and Marketed by:

Pyratine LLC

2950 Main Street

Morro Bay, CA 93442

1-888-467-9728

www.pyratine.com

Image Pyratine XRImage Pyratine XR

Image Pyratine XRImage Pyratine XR

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62742-4145-1Pyratine XR Creme With Sunscreen Broad Spectrum SPF3056.7 g in 1 TUBECREAM56.71
62742-4145-2Pyratine XR Creme With Sunscreen Broad Spectrum SPF301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62742-4145PYRATINE XR CREME WITH SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE) CREAM [ALLURE LABS INC]1Current NDC, Legacy NDC, 2 package rows20171208_fc316b19-c1cf-4b5b-9f22-9672b7d0cbff.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
62742-414562742-4145-1, 62742-4145-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
IMPERATA CYLINDRICA ROOTVYT2JA85NHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOMER 1342809Y72KV36IACT
CETYL ALCOHOL936JST6JCNIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
XANTHAN GUMTTV12P4NEEIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-G0N132Q0EDIACT
TEPRENONES8S8451A4OIACT
DATEH3O7QI5HY7IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
SODIUM LACTATETU7HW0W0QTIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
ARABIDOPSIS THALIANAAI3L60HQ81IACT
MICROCOCCUS LUTEUSLV6L29Z6AXIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

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
Pyratine XR Creme With Sunscreen Broad Spectrum SPF30ZINC OXIDEAllure Labs Incfc316b19-c1cf-4b5b-9f22-9672b7d0cbff2017-12-07WarningsExact identifier
ndc (package): 62742-4145-1
ndc (package): 62742-4145-2
ndc (product): 62742-4145
ndc11 (package): 62742414501
ndc11 (package): 62742414502
spl id: 8e9f9e3a-6bd4-4a35-b859-ad14ff81e53b
spl set id: fc316b19-c1cf-4b5b-9f22-9672b7d0cbff

Reported adverse events (FAERS/openFDA)#

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