KLENSKIN SHOWERON SUNSCREEN
- Manufacturer
- CoLabs Intl. Corp
- Effective date
- 2022-02-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:17
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS
AVOBENZONE 2.75%
OCTOCRYLENE 7.04%
OCTINOXATE 7.2%
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 INGREDIENT SECTION
INACTIVE INGREDIENTS
WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYSORBATE 20, GLYCERIN, POLYQUATERNIUM-10, SORBITAN MONOOLEATE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN, BUTYROSPERMUM PARKII (SHEA) OIL, DIMETHICONE, POLYAMIDE-3, SORBITAN STEARATE, CARBOXYMETHYCELLULOSE NA, ETHYLENEDIAMINE/STEARYL DIMER DILINOLEATE COPOLYMER, PG HYDROXYETHYLCELLULOSE STEARDIMONIUM CHLORIDE, SODIUM LAURYL GLUCOSE CARBOXYLATE, PHENOXYETHANOL, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, CAPRYLYL GLYCOL, TETRASODIUM EDTA, LAURYLDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDES CHLORIDE, GELLAN GUM, SODIUM ALGINATE, ARCTIUM LAPPA (BURDOCK ROOT) EXTRACT, LAURYL GLUCOSIDE, CAMELIA OLEIFERA (GREEN TEA) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, RUBEUS IDAEUS (RED RASPBERRY) OIL, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, CARRAGEENAN, CITRIC ACID, SODIUM CHLORIDE
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61369-101-18 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fe3e-111a-e063-dadaa90a10e2 | COLABS - Klenskin Wash On Shampoo, Face & Body Wash SPF 30, Fragrance Free (61369-101) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61369-101-18 | KLENSKIN SHOWERON SUNSCREENSPF-30 | 236 mL in 1 BOTTLE | GEL | 236 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 4 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 4 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 4 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 4 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 4 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 4 | |
| ARCTIUM LAPPA ROOT | INACTIVE INGREDIENT | 597E9BI3Z3 | 4 | |
| CAMELLIA OLEIFERA SEED | INACTIVE INGREDIENT | 59ED29FM2J | 4 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 4 | |
| CARBOMER COPOLYMER TYPE A | INACTIVE INGREDIENT | 71DD5V995L | 4 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 4 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | 4 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 4 | |
| CRANBERRY SEED OIL | INACTIVE INGREDIENT | 73KDS3BW5E | 4 | |
| DIISOSTEARYL DIMER DILINOLEATE | INACTIVE INGREDIENT | 04P17590AP | 4 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 4 | |
| DISTEARYLDIMONIUM CHLORIDE | INACTIVE INGREDIENT | OM9573ZX3X | 4 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 4 | |
| ETHYLENEDIAMINE | INACTIVE INGREDIENT | 60V9STC53F | 4 | |
| GELLAN GUM (LOW ACYL) | INACTIVE INGREDIENT | 7593U09I4D | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| GRAPE SEED OIL | INACTIVE INGREDIENT | 930MLC8XGG | 4 | |
| HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) | INACTIVE INGREDIENT | ZR28QKN0WT | 4 | |
| HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) | INACTIVE INGREDIENT | R33S7TK2EP | 4 | |
| HYDROXYETHYL LAURDIMONIUM CHLORIDE | INACTIVE INGREDIENT | 8467K53E3Y | 4 | |
| LAURYL GLUCOSIDE | INACTIVE INGREDIENT | 76LN7P7UCU | 4 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 4 | |
| POLYACRYLAMIDE (1500 MW) | INACTIVE INGREDIENT | 5D6TC4BRWV | 4 | |
| POLYQUATERNIUM-10 (125 MPA.S AT 2%) | INACTIVE INGREDIENT | L45WU8S981 | 4 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 4 | |
| POMEGRANATE SEED OIL | INACTIVE INGREDIENT | 0UI45XV0T6 | 4 | |
| RASPBERRY SEED OIL | INACTIVE INGREDIENT | 9S8867952A | 4 | |
| SHEANUT OIL | INACTIVE INGREDIENT | O88E196QRF | 4 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 4 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | 4 | |
| SODIUM LAURYL GLYCOL CARBOXYLATE | INACTIVE INGREDIENT | 8L0472VMYL | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | 4 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- KLENSKIN SHOWERON SUNSCREEN SPF-30
- AVOBENZONE, OCTOCRYLENE, OCTINOXATE
- WATER
- SODIUM LAURETH SULFATE
- SODIUM LAURYL SULFATE
- COCAMIDOPROPYL BETAINE
- POLYSORBATE 20
- GLYCERIN
- POLYQUATERNIUM-10 (125 MPA.S AT 2%)
- SORBITAN MONOOLEATE
- HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW)
- SHEANUT OIL
- DIMETHICONE
- POLYACRYLAMIDE (1500 MW)
- SORBITAN MONOSTEARATE
- CARBOXYMETHYLCELLULOSE SODIUM
- DILINOLEIC ACID/ETHYLENEDIAMINE COPOLYMER
- HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
- DISTEARYLDIMONIUM CHLORIDE
- SODIUM LAURYL GLYCOL CARBOXYLATE
- PHENOXYETHANOL
- CARBOMER COPOLYMER TYPE A
- CAPRYLYL GLYCOL
- EDETATE SODIUM
- HYDROXYETHYL LAURDIMONIUM CHLORIDE
- GELLAN GUM (LOW ACYL)
- SODIUM ALGINATE
- LAURYL GLUCOSIDE
- ARCTIUM LAPPA ROOT
- CAMELLIA OLEIFERA SEED
- POMEGRANATE SEED OIL
- RASPBERRY SEED OIL
- CRANBERRY SEED OIL
- GRAPE SEED OIL
- CARRAGEENAN
- ANHYDROUS CITRIC ACID
- SODIUM CHLORIDE
- AVOBENZONE
- OCTOCRYLENE
- OCTINOXATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61369-101 | 61369-101-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM ALGINATE | SODIUM ALGINATE | C269C4G2ZQ | SYRUP / ORAL | 3 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUPPOSITORY / VAGINAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | AEROSOL, FOAM / TOPICAL | 0.55 %w/w | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | CAPSULE / ORAL | 288 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / ENDOTRACHEAL | 68 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GRANULE, FOR SUSPENSION / ORAL | 15.63 mg/5ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | CREAM / VAGINAL | 0.75 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| ETHYLENEDIAMINE | ETHYLENEDIAMINE | 60V9STC53F | INJECTION / INTRAVENOUS | 0.39 %w/v | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | TABLET / ORAL | 15 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | SUSPENSION / ORAL | 6 mg/5ml | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / SUBCUTANEOUS | NA | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / VAGINAL | 100 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAVITREAL | 0.5 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | SHAMPOO / TOPICAL | 65 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | GRANULE, FOR SUSPENSION / ORAL | 161 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SYSTEM / IONTOPHORESIS | 3.1 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION / ENTERAL | 2920 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 100 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / PARENTERAL | 210 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| SODIUM LAURETH SULFATE | SODIUM LAURETH-3 SULFATE | BPV390UAP0 | CREAM / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRASYNOVIAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SOLUTION / OPHTHALMIC | 0.9 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRA-ARTICULAR | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, FILM COATED / ORAL | 240 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBCUTANEOUS | 1486 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | EMULSION / TOPICAL | 34050 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SOLUTION / ORAL | 1080 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PASTE / DENTAL | 1.5 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d8288a2c-dc92-cc66-e053-2a95a90a7c4e | 00d73e47-97fd-4fe7-80d4-bf19ed0c9dda | 2022-02-16 | Warnings | d8288a2c-dc92-cc66-e053-2a95a90a7c4e 00d73e47-97fd-4fe7-80d4-bf19ed0c9dda |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
