FDA.reportPublic FDA data

KLENSKIN SPF LIP BALM BROAD SPECTRUM

Manufacturer
CoLabs Intl. Corp
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:07:14

Label at a glance#

ProductKLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS)
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure11 sections

Indications and uses

Helps prevent sunburn If used as directed with othersun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: • At least every 2 hours

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.3%

Homosalate 9.2%

Octisalate 4.3%

PURPOSE

OTC - PURPOSE SECTION

SUNSCREEN

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with othersun protection measures (see Directions), decreases therisk of skin cancer and early skin aging caused by the sun.

WARNINGS

WARNINGS SECTION

  • For external use only
  • Do not use ondamaged or broken skin. When using this product, keepout of eyes and rinse with excessive water to remove.

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.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

  • Reapply: • At least every 2 hours

OTHER INFORMATION

OTHER SAFETY INFORMATION

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 of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10a.m.-2p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a doctor.

• Protect this product from excessive heat & direct sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cera Alba (Beeswax), Caprylic/Capric Triglyceride, Water, Polyethylene, Theobroma Cacao (Cocoa) Seed Butter, Bis-PEG-18 Methyl Ether Dimethyl Silane, Flavor, Butyrospermum parkii (Shea) Butter, Sorbitan Stearate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Octyldecanol, Trimethoxybenzylidene Pentanedione, Stevia Rebaudiana Leaf Extact, Sodium Saccharin, Tocopheryl Acetate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Punica Granatum (Pomegranate) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Chitosan, Algin, Phenoxyethanol, Ethylhexylglycerin

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

PLEASE CALL TOLL FREE 888.878.5536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KLENSKIN_2_1875x3_9688_CHERRYKLENSKIN_2_1875x3_9688_CHERRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-301-23KLENSKIN SPF LIP BALM BROAD SPECTRUMSPF-50 (ALL FLAVORS)4.25 g in 1 TUBELIPSTICK4.259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-301KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS) (AVOBENZONE, HOMOSALATE, OCTISALATE) LIPSTICK [COLABS INTL. CORP]9Legacy NDC, 1 package rows20240116_118fd112-4085-4a76-bb64-46c57b3a6377.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61369-30161369-301-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
COCOA BUTTER512OYT1CRRIACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
SHEA BUTTERK49155WL9YIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
OCTYLDODECANOL461N1O614YIACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CRANBERRY SEED OIL73KDS3BW5EIACT
GRAPE SEED OIL930MLC8XGGIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
TEA TREE OILVIF565UC2GIACT
CHITOSAN HIGH MOLECULAR WEIGHT (400-800 MPA.S)7SRJ3W89J8IACT
SODIUM ALGINATEC269C4G2ZQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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
0f03c8f8-218c-400e-e063-6294a90aa966118fd112-4085-4a76-bb64-46c57b3a63772024-01-15WarningsExact identifier
spl id: 0f03c8f8-218c-400e-e063-6294a90aa966
spl set id: 118fd112-4085-4a76-bb64-46c57b3a6377

Reported adverse events (FAERS/openFDA)#

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