Cover Fx Invisible Primer Spf30 Lotion
FDA Label NDC 68577-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa, Corporation for the product Cover Fx Invisible Primer Spf30 (NDC 68577-105). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%

OCTOCRYLENE 2.6%

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 Doctor

if rash occurs.

Keep Out Of The Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun.
  • Children under 6 months: Ask a doctor.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply 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 value of 15 or higher and take other sun protection measures.
  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sunlight.

Inactive Ingredients

ISODODECANE, DIMETHICONE/ BIS-ISOBUTYL PPG-20 CROSSPOLYMER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, TOCOPHERYL ACETATE, SQUALANE, TOCOPHEROL, SILICA, DIMETHYL ISOSORBIDE.

Questions?

Email: customerservice@cover fx.com M – F, 10 a.m. – 5 p.m. EST

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