FDA.reportPublic FDA data

COCOOIL SPF 15

Manufacturer
Cocooil Limited
Effective date
2018-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:07

Label at a glance#

ProductCOCOOIL SPF 15
Active ingredientOCTINOXATE, OCTOCRYLENE, AVOBENZONE
Label structure8 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 waterresistant sunscreen if sweating or swimming. Sun Protection  Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 between 10 am and 2 pm WEAR long sleeved sh...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octyl methoxycinnamate 7.5%,
Octocrylene 5%, 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 only

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 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 Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

APPLY liberally 15 minutes before sun exposure

  • USE a waterresistant sunscreen if sweating or swimming.

Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 between 10 am and 2 pm
  • 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 ingredients

INACTIVE INGREDIENT SECTION

HELIANTHUS ANNUUS SEED OIL, Cold pressed Certified Organic COCOS NUCIFERA OIL, BEESWAX, PARFUM, TOCOPHEROL

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72645-015-002021-01-29C16284748780-1ba0f9c33-5648-a910-e053-dadaa90a0b85COCOOIL SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72645-015-00COCOOIL SPF 15200 mL in 1 BOTTLELOTION2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72645-015COCOOIL SPF 15 (OCTINOXATE, OCTOCRYLENE, AVOBENZONE) LOTION [COCOOIL LIMITED]2Legacy NDC, 1 package rows20181101_759e871d-c1d6-4e04-a567-deb53d36a117.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72645-01572645-015-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
YELLOW WAX2ZA36H0S2VIACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
7984adbf-a095-73f4-e053-2a91aa0af8c6759e871d-c1d6-4e04-a567-deb53d36a1172018-10-31WarningsExact identifier
spl id: 7984adbf-a095-73f4-e053-2a91aa0af8c6
spl set id: 759e871d-c1d6-4e04-a567-deb53d36a117

Reported adverse events (FAERS/openFDA)#

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