FDA.reportPublic FDA data

BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA

Manufacturer
ENGLEWOOD LAB, INC.
Effective date
2023-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:09

Label at a glance#

ProductBEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 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 Use a water resistant sunscreen if swimming or sweating  Reapply at least every 2 hours Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  Sun Protection Measures. Limit time in the sun, especially fro...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 3%

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

  • Avoid contact with eyes. 
  • For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating 
  • Reapply at least every 2 hours
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:  Sun Protection Measures.
  • 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: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sunlight.   
  • You may report a serious adverse event from use of this product to: team@kravebeauty.com

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Propanediol, Pentylene Glycol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Bisabolol, Ethylhexyl Methoxycrylene, Hydroxyacetophenone, Beta Vulgaris (Beet) Root Extract, Isohexadecane, Polysorbate 80, Hyaluronic Acid, Tocopheryl Acetate, Caprylyl Glycol, Eugenia Caryophyllus Bud Extract, Solidago Virgaurea Extract, Salix Alba (Willow) Bark Extract, Trisodium Ethylenediamine Disuccinate, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Citric Acid, Sodium Hydroxide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14268-118-50BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA50 mL in 1 TUBELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14268-118BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ENGLEWOOD LAB, INC.]3Current NDC, 1 package rows20231213_f5c795f0-63bc-3033-e053-2995a90a55ab.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14268-11814268-118-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
PENTYLENE GLYCOL50C1307PZGIACT
SODIUM ACRYLATE7C98FKB43HIACT
LEVOMENOL24WE03BX2TIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
BEETN487KM8COKIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
HYALURONIC ACIDS270N0TRQYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SALIX ALBA BARK205MXS71H7IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXIDE55X04QC32IIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c795f0-63bc-3033-e053-2995a90a55ab2023-12-12WarningsExact identifier
ndc (package): 14268-118-50
ndc (product): 14268-118
ndc11 (package): 14268011850
spl id: 0c5be140-80f1-1501-e063-6294a90a3faf
spl set id: f5c795f0-63bc-3033-e053-2995a90a55ab

Reported adverse events (FAERS/openFDA)#

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