FDA.reportPublic FDA data

KLENSKIN BROAD SPECTRUM SUNSCREEN

Manufacturer
CoLabs Intl. Corp
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:16

Label at a glance#

ProductKLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure11 sections

Indications and uses

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, SWEATING OR EXPOSURE TO WATER IMMEDIATELY AFTER TOWEL DRYING, 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

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.

WARNINGS

WARNINGS SECTION

  • FOR EXTERNAL USE ONLY
  • DO NOT USE ON DAMAGED OR BROKEN SKIN.
  • WHEN USING THIS PRODUCT, KEEP OUT 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:
  • AFTER 80 MINUTES OF SWIMMING, SWEATING OR EXPOSURE TO WATER
  • IMMEDIATELY AFTER TOWEL DRYING, AT LEAST EVERY 2 HOURS

OTHER SAFETY INFORMATION

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 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: ASK A DOCTOR.

OTHER INFORMATION

  • PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT EXPOSURE TO SUNLIGHT.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CERA ALBA (BEESWAX), WATER, CAPRYLIC/CAPRIC TRIGLYCERIDE, BIS-PEG-METHYL ETHER DIMETHYL SILANE, POLYETHYLENE, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, SORBITAN STEARATE, SORBITAN OLEATE, POLYSORBATE 20, TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER, OCTYLDECANOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, TRIMETHOXYBENZYLIDENE PENTANEDIONE, POLYAMIDE-3, ALGIN, CHITOSAN

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

PLEASE CALL TOLL FREE 888.878.5536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_SPF-30 Sunscreen Stick_front01b LBL_SPF-30 Sunscreen Stick_front

01b LBL_SPF-30 Sunscreen Stick_back01b LBL_SPF-30 Sunscreen Stick_back

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-105-11KLENSKIN BROAD SPECTRUM SUNSCREENSPF-3014.2 g in 1 TUBESTICK14.26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-105KLENSKIN BROAD SPECTRUM SUNSCREEN SPF-30 (AVOBENZONE, HOMOSALATE, OCTISALATE) STICK [COLABS INTL. CORP]6Legacy NDC, 1 package rows20240116_da53cae0-ffe6-4596-94be-78b4d4e4aeab.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61369-10561369-105-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BIS-PEG-18 METHYL ETHER DIMETHYL SILANEOEB4R3WW9CIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
POLYSORBATE 207T1F30V5YHIACT
TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S)587WKM3S9QIACT
OCTYLDODECANOL461N1O614YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CRANBERRY SEED OIL73KDS3BW5EIACT
GRAPE SEED OIL930MLC8XGGIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
TEA TREE OILVIF565UC2GIACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
POLYAMIDE-3 (12000 MW)L7P3YWF22XIACT
SODIUM ALGINATEC269C4G2ZQIACT
POLIGLUSAM82LKS4QV2YIACT
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
0f03a8e5-d9b1-3134-e063-6294a90ae931da53cae0-ffe6-4596-94be-78b4d4e4aeab2024-01-15WarningsExact identifier
spl id: 0f03a8e5-d9b1-3134-e063-6294a90ae931
spl set id: da53cae0-ffe6-4596-94be-78b4d4e4aeab

Reported adverse events (FAERS/openFDA)#

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