Cao Cosmetic Lip Sunscreen Spf 30 Ointment
FDA Label NDC 82564-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by S & J International Enterprises Public Company Limited for the product Cao Cosmetic Lip Sunscreen Spf 30 (NDC 82564-000). 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, use, warnings, do not use, when using this product, stop use and ask a doctor if, 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

Avobenzone 2.8%

Octocrylene 5%

Purpose

Sunscreen

Use

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor

Other Information

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

diisostearyl malate, hydrogenated polyisobutene, bis-diglyceryl polyacyladipate-2, isopropyl myristate, microcrystalline wax, shea  (Butyrospermum parkii) butter, isoamyl p-methoxycinnamate, silica, polyglyceryl-3 diisostearate, tocopheryl acetate, fragrance (parfum), argan tree (Argania spinosa) kernel oil, coconut (Cocos nucifera) oil, water (aqua), butylene glycol, peach (Prunus persica) leaf extract, benzyl benzoate.

Package Labeling:

Updatedlabel (Updatedlabel6g)

Updatedlabel (Updatedlabel6g)

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