Cocooil Spf 15
FDA Label NDC 72645-015

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cocooil Limited for the product Cocooil Spf 15 (NDC 72645-015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Octyl methoxycinnamate 7.5%,
Octocrylene 5%, Avobenzone 3%

Purpose

Sunscreen

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

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 A Doctor

  • if rash occurs

Keep Out Of Reach Of Children

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

Directions

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

• Protect this product from excessive heat and direct sun

Inactive Ingredients

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

Questions?

Visit www.cocooil.com.au or call +64 9 361 4191

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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