FDA.reportPublic FDA data

COOLA Full Spectrum 360 Sun Silk Drops

Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:17

Label at a glance#

ProductCOOLA Full Spectrum 360 Sun Silk Drops SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%

Octisalate 5.0%, Octocrylene 6.0%

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 rise of skin cancer and early skin aging caused by the sun

WARNINGS AND PRECAUTIONS SECTION

Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask doctor if skin rash occurs
Keep out of reach of children. If prodcut is swallowed, get medical help or contact Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask doctor if skin rash occurs

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.

DOSAGE & ADMINISTRATION SECTION

Directions
* shake well * apply liberally 15 minutes before sun exposure
* reapply: * after swimming or sweating * immediately after towel drying * at least every 2 hours
* Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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-sleeve shirts, pants, hats, and sunglasses
* children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract (Organic), Anthemis Nobilis (Chamomile) Flower Oil, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Organic Safflower) Seed Oil, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Leaf/Twig Extract, Dicaprylyl Carbonate, Glycerin (Organic), Glyceryl Stearate Se, Jasminum Sambac (Jasmine) Leaf Cell Extract, Nylon-12, Olea Europaea (Organic Olive) Fruit Oil, Plankton Leaf Extract, Propanediol, Schinus Molle Extract, Simmondsia Chinensis (Organic Jojoba) Seed Oil, Sodium Benzoate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Extract, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

OTHER SAFETY INFORMATION

Other information
* protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call 760-940-2125

INSTRUCTIONS FOR USE SECTION

How to use:

Apply daily to cleansed skin. For best

results, dispense several drops as needed

into palm of hand and apply evenly across

face and neck using upward strokes. Drops

are perfect for use alone or blended with

your everyday skincare and makeup.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILK SUN DROPS 30 ML BOTTLESILK SUN DROPS 30 ML BOTTLESUN SILK DROPS 1 FL SPF 30SUN SILK DROPS 1 FL SPF 30

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-620-022021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30
21839-620-042021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-620-01COOLA Full Spectrum 360 Sun Silk DropsSPF 305 mL in 1 BOTTLELIQUID51
21839-620-02COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 NOT APPLICABLELIQUID11
21839-620-03COOLA Full Spectrum 360 Sun Silk DropsSPF 3030 mL in 1 BOTTLELIQUID301
21839-620-04COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-620COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 4 package rows20191224_9a03c1f7-098e-035d-e053-2a95a90a1fef.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21839-62021839-620-01, 21839-620-02, 21839-620-03, 21839-620-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPANEDIOL5965N8W85TIACT
OLIVE OIL6UYK2W1W1EIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVOBENZONEG63QQF2NOXACTIB
COCOAD9108TZ9KGIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CITRUS AURANTIUM FLOWER OILD4BGE91OXHIACT
SAFFLOWER OIL65UEH262ISIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
NYLON-12446U8J075BIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT
OCTOCRYLENE5A68WGF6WMACTIB
XANTHAN GUMTTV12P4NEEIACT
JOJOBA OIL724GKU717MIACT
GLYCERINPDC6A3C0OXIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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
9a03c1f7-098f-035d-e053-2a95a90a1fef9a03c1f7-098e-035d-e053-2a95a90a1fef2019-12-18WarningsExact identifier
spl id: 9a03c1f7-098f-035d-e053-2a95a90a1fef
spl set id: 9a03c1f7-098e-035d-e053-2a95a90a1fef

Reported adverse events (FAERS/openFDA)#

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