FDA.reportPublic FDA data

Fragrance Free Reef Friendly Sunscreen Lotion Broad Spectrum SPF 30

Manufacturer
Prime Enterprises Inc.
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:31

Label at a glance#

ProductCORETEX Broad Spectrum SPF 30 Sunscreen
Active ingredientHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure9 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 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Octocrylene 3.5%

Homosalate 10%

Octisalate 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

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 - ASK DOCTOR 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

  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Ethylhexylglycerin, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polyethylene, Polysorbate 20, Propanediol, Sodium Hydroxide, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trisodium Ethylenediamine Disuccinate, Water

Other Information

OTHER SAFETY INFORMATION

  • protect this product in this container from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-950-2563

ALOE UP SPORT PERFORMANCE SUNSCREEN LOTION Broad spectrum SPF 50 - 89 mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0420-12023-01-30C16284748780-1f386c649-fa0a-0266-e053-dadaa90a7c1aFragrance Free Reef Friendly Sunscreen Lotion Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0420-1CORETEXBroad Spectrum SPF 30 Sunscreen18927 mL in 1 CONTAINERLOTION189271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0420CORETEX BROAD SPECTRUM SPF 30 SUNSCREEN (OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20211028_cba53e73-c7ef-44c1-e053-2995a90aec80.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-042058443-0420-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
COCOA BUTTER512OYT1CRRIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYSORBATE 207T1F30V5YHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYPROMELLOSES3NXW29V3WOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
cba54d03-42fe-5989-e053-2a95a90a5a24cba53e73-c7ef-44c1-e053-2995a90aec802021-09-10WarningsExact identifier
spl id: cba54d03-42fe-5989-e053-2a95a90a5a24
spl set id: cba53e73-c7ef-44c1-e053-2995a90aec80

Reported adverse events (FAERS/openFDA)#

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