FDA.reportPublic FDA data

COOLA Sun Silk Drops SPF 30

Manufacturer
COOLA LLC
Effective date
2021-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:13

Label at a glance#

ProductCOOLA Sun Silk Drops SPF 30
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Avobenzone 3%, Octisalate 4%, Octocrylene 8%

OTC - PURPOSE SECTION

Purpose

Suncreen

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. 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 80 minutes of 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 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-sleeve shirts, pants, hats, and sunglasses
● Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC),
Butyloctyl Salicylate, Glycerin (ORGANIC),
Polyglyceryl-6 Stearate, Carthamus Tinctorius
(Safflower) Seed Oil (ORGANIC), Olea Europaea
(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis
(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao
(Cocoa) Seed Extract, Jasminum Sambac
(Jasmine) Leaf Cell Extract, Schinus Molle Extract,
Sodium Hyaluronate, Sodium Hydroxide, Plankton
Extract, Water, Ethyl Ferulate, Propanediol,
Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,
Glyceryl Stearate, Hydroxyacetophenone,
Polyglyceryl-6 Behenate, Acrylates/10-30 Alkyl
Acrylate Crosspolymer, Sodium Phylae,
Tocopheryl Acetate, Fragrance (Natural)

OTHER SAFETY INFORMATION

Other information

  • protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments?  Call 760-940-2125

COOLA Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF

30

70%+

Organic

COOLA​®

Sun Silk Drops

Sunscreen

1.0 FL OZ / 30 mL

*SPF value may decrease if blended.

For detailed instructions, see insert.

©2021 COOLA. Distributed by: COOLA LLC,

located in Sunny & Cool San Diego, CA 92010. 

All Rights Reserved. 

www.coola.com

Carton

038 SubSilk038 SubSilk

Bottle

038 Botl038 Botl

res

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
79753-038-012023-01-30C16284748780-1f386c64a-3d77-0266-e053-dadaa90a7c1aCOOLA Sun Silk Drops SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-038-01COOLA Sun Silk Drops SPF 3030 mL in 1 BOTTLELIQUID302
79753-038-01COOLA Sun Silk Drops SPF 301 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-038COOLA SUN SILK DROPS SPF 30 (AVOBENZONE 3%, OCTISALATE 4%, OCTOCRYTENE 8%) LIQUID [COOLA LLC]2Legacy NDC, 2 package rows20210901_c0c07144-2e32-4a61-a516-bcf44dd04812.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
79753-03879753-038-01

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
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERSR2Z4507WJNIACT
OLIVE OIL6UYK2W1W1EIACT
JOJOBA OIL724GKU717MIACT
COCOAD9108TZ9KGIACT
JASMINUM SAMBAC FLOWER2S686I937FIACT
SCHINUS MOLLE FRUITING TOPT8L6O1KSB4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT
ARTHROSPIRA PLATENSIS9L3TIH1UUEIACT
WATER059QF0KO0RIACT
ETHYL FERULATE5B8915UELWIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PHYTATE SODIUM88496G1ERLIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
ee3195db-da54-4d96-a932-def1dd421563c0c07144-2e32-4a61-a516-bcf44dd048122021-05-07WarningsExact identifier
spl id: ee3195db-da54-4d96-a932-def1dd421563
spl set id: c0c07144-2e32-4a61-a516-bcf44dd04812

Reported adverse events (FAERS/openFDA)#

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