FDA.reportPublic FDA data

Cocooil SPF50

Manufacturer
Cocooil Limited
Effective date
2020-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:37

Label at a glance#

ProductCocooil SPF50
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure9 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 USE a water resistant sunscreen if sweating or swimming. Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decreases risk, regularly use a sunsreen with a broad spectrum SPF of 15 or higher and other sun protection measures including LIMIT time in the sun especially between 10am and 2pm WEAR long sleeved shir...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%, Octocrylene 8%, Octyl methoxycinnamate 7.5%

Octisalate 5%, Oxybenzone 4%, Avobenzone 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 ony

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin   

When using this product 

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if a rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If this product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

APPLY liberally 15 minutes before sun exposure

  • USE a water resistant sunscreen if sweating or swimming. Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decreases risk, regularly use a sunsreen with a broad spectrum SPF of 15 or higher and other sun protection measures including
  • LIMIT time in the sun especially between 10am and 2pm
  • WEAR long sleeved shirts, pants, hats and sunglasses
  • REAPPLY at least every 2 hours
  • USE a water resistant sunscreen if sweating or swimming 
  • Children under 6 months ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun

Inactive ingrediets

INACTIVE INGREDIENT SECTION

CAPRYLIC/CAPROC TRIGLYCERIDE, HELIANTHUS ANNUUS SEED OIL, Cold pressed organic COCOS NUCIFERA OIL, C12-15 ALKYL BENZOATE, BEESWAX, BUTYROSPERMUM PARKII BUTTER, TRIACONTANYL PVP, PARFUM, TOCOPHEROL

Package Labeling: 100 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling: 200 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72645-003-012022-01-28C16284748780-1d6a99b39-8b2a-a426-e053-dadaa90af4c2Cocooil SPF50
72645-003-022022-01-28C16284748780-1d6a99b39-8b2a-a426-e053-dadaa90af4c2Cocooil SPF50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72645-003-01Cocooil SPF50100 mL in 1 BOTTLELOTION1001
72645-003-02Cocooil SPF50200 mL in 1 BOTTLELOTION2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72645-003COCOOIL SPF50 (HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE, AVOBENZONE) LOTION [COCOOIL LIMITED]1Legacy NDC, 2 package rows20200505_a4d7855b-c9ac-c8de-e053-2995a90ae4b0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72645-00372645-003-01, 72645-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
YELLOW WAX2ZA36H0S2VIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
TOCOPHEROLR0ZB2556P8IACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB

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
a4d771ca-7450-828c-e053-2995a90a3061a4d7855b-c9ac-c8de-e053-2995a90ae4b02020-05-04WarningsExact identifier
spl id: a4d771ca-7450-828c-e053-2995a90a3061
spl set id: a4d7855b-c9ac-c8de-e053-2995a90ae4b0

Reported adverse events (FAERS/openFDA)#

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