FDA.reportPublic FDA data

COLABS - KLENSKIN SUNSCREEN - FACE & BODY SPF 30 SUNSCREEN GEL (61369-202)

Manufacturer
CoLabs Intl. Corp
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:13

Label at a glance#

ProductKLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure12 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, SWEATING OR EXPOSURE TO WATER     IMMEDIATELY AFTER TOWEL DRYING     AT LEAST EVERY 2 HOURS

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

HOMOSALATE 9.75%

OCTISALATE 5%

ZINC 10.3%

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

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Acrylates Copolymer, Caprylic/Capric Triglyceride, Diatomaceous Earth, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Phenoxyethanol, Ricinus Comminus (Castor) Seed Oil, Hydrogenated Castor Oil, Cetyl Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Rubeus Idaeus (Red Raspberry) Oil, Vitus Vinifera (Grape) Seed Oil, Tocopheryl Acetate, Cucumis Sativua (Cucumber) Seed Oil, Butyrospermum Parkii (Shea) Oil

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

PLEASE CALL TOLL FREE 888.878.5536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Sunscreen Face-Body SPF30_3oz01b LBL_Sunscreen Face-Body SPF30_3oz

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-202-13KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUMSPF 3088 mL in 1 TUBEGEL884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-202KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, ZINC) GEL [COLABS INTL. CORP]4Legacy NDC, 1 package rows20240116_0c5d339c-6e7c-4287-b261-a0f5f8fdd06d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61369-20261369-202-13

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
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CUCUMBER SEED OILAKP926H71PIACT
SHEA BUTTERK49155WL9YIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIATOMACEOUS EARTH2RF6EJ0M85IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CASTOR OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CETYL DIMETHICONE 45IK315POC44IACT
JOJOBA OIL724GKU717MIACT
RASPBERRY SEED OIL9S8867952AIACT
GRAPE SEED OIL930MLC8XGGIACT

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
0f03c4cb-33b3-1a0e-e063-6394a90a03890c5d339c-6e7c-4287-b261-a0f5f8fdd06d2024-01-15WarningsExact identifier
spl id: 0f03c4cb-33b3-1a0e-e063-6394a90a0389
spl set id: 0c5d339c-6e7c-4287-b261-a0f5f8fdd06d

Reported adverse events (FAERS/openFDA)#

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