FDA.reportPublic FDA data

COLABS - KLENSKIN SUNSCREEN - FACE & BODY SPF 50 SUNSCREEN LOTION (61369-201)

Manufacturer
CoLabs Intl. Corp
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:07:14

Label at a glance#

ProductKLENSKIN BROAD SPECTRUM SPF-50
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTINOXATE
Label structure11 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 2.1%

OCTINOXATE 5%

OCTOCRYLENE 5.4%

OTC - PURPOSE SECTION

PURPOSE

SUNSCREEN

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 SECTION

WARNINGS

  • 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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • SHAKE WELL BEFORE USE
  • 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 SUNLIGHT.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Acrylates Copolymer, Dimethicone, Vinyldimethyl/Trimethylsiloxysilicate/Dimethicone Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Polysorbate 20, Sorbitan Monooleate, Cocodimonium Hydroxypropyl Hydrolyzed Keratin, Butyrospermum Parkii (Shea) Oil, Polyamide 3, Carboxymethylcellulose Na,
Ethylenediamine/Stearyl Dimer Dilinoleate Copolymer, PG Hydroxyethylcellulose Stearyldimonium Chloride, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Laurdimoniumhydroxypropyl Decylglucosides Chloride, Gellan Gum, Sodium Alginate, Carrageenan, Tocopheryl Acetate, Rubeus Idaeus (Red Raspberry) Oil, Punica Granatum (Pomegranate) Seed Oil, Camellia Oleifera (Organic Green Tea) Seed Oil, Arctium Lappa Root Extract (Burdock Root), Phenoxyethanol, Trimethoxybenzylidene Pentanedione, Caprylyl Glycol

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KLENSKIN_4oz_SPF50_Lotion_final v6KLENSKIN_4oz_SPF50_Lotion_final v6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61369-201-122026-01-29C16284748780-149896155-ab61-586f-e063-e6dba90add90COLABS - KLENSKIN SUNSCREEN - FACE & BODY SPF 50 SUNSCREEN LOTION (61369-201)
61369-201-142026-01-29C16284748780-149896155-ab61-586f-e063-e6dba90add90COLABS - KLENSKIN SUNSCREEN - FACE & BODY SPF 50 SUNSCREEN LOTION (61369-201)
61369-201-322026-01-29C16284748780-149896155-ab61-586f-e063-e6dba90add90COLABS - KLENSKIN SUNSCREEN - FACE & BODY SPF 50 SUNSCREEN LOTION (61369-201)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-201-12KLENSKIN BROAD SPECTRUMSPF-5056 mL in 1 BOTTLELOTION5612
61369-201-14KLENSKIN BROAD SPECTRUMSPF-50118 mL in 1 BOTTLELOTION11812
61369-201-32KLENSKIN BROAD SPECTRUMSPF-50946 mL in 1 BOTTLELOTION94612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-201KLENSKIN BROAD SPECTRUM SPF-50 (AVOBENZONE, OCTOCRYLENE, OCTINOXATE) LOTION [COLABS INTL. CORP]12Legacy NDC, 3 package rows20240116_63fec681-5957-49cc-8b9e-97c4819ce097.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61369-20161369-201-12, 61369-201-14, 61369-201-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
DIMETHICONE92RU3N3Y1OIACT
VINYLDIMETHYL/TRIMETHYLSILOXYSILICATE STEARYL DIMETHICONE CROSSPOLYMER01S784FLCOIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)J2S07SB0YLIACT
SHEANUT OILO88E196QRFIACT
POLYAMIDE-3 (12000 MW)L7P3YWF22XIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ETHYLENEDIAMINE60V9STC53FIACT
DIISOSTEARYL DIMER DILINOLEATE04P17590APIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
SODIUM LAURYL GLYCOL CARBOXYLATE8L0472VMYLIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
LAURDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDE CHLORIDEGCO3569D5LIACT
GELLAN GUM (LOW ACYL)7593U09I4DIACT
SODIUM ALGINATEC269C4G2ZQIACT
CARRAGEENAN5C69YCD2YJIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
RASPBERRY SEED OIL9S8867952AIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
CAMELLIA SINENSIS SEED OILO5R6DK2M9KIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRIMETHOXYBENZYLIDENE PENTANEDIONE322V0ACF25IACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
0f03c0d9-6edc-36c1-e063-6294a90a5d3963fec681-5957-49cc-8b9e-97c4819ce0972024-01-15WarningsExact identifier
spl id: 0f03c0d9-6edc-36c1-e063-6294a90a5d39
spl set id: 63fec681-5957-49cc-8b9e-97c4819ce097

Reported adverse events (FAERS/openFDA)#

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