Active Ingredients
Homosalate 7.3%
Octisalate 5.0%
Zinc Oxide 6.5%
Essence Pout Protector Spf 20 Lip Balm Stick
FDA Label NDC 84270-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosnova Gmbh for the product Essence Pout Protector Spf 20 Lip Balm (NDC 84270-001). 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
Purpose
Sunscreen
Uses
- 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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
RICINUS COMMUNIS (CASTOR) SEED OIL, EUPHORBIA CERIFERA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX, BIS-DIGLYCERYL POLYACYLADIPATE-1, BUTYROSPERMUM PARKII (SHEA) BUTTER, RUBUS IDAEUS (RASPBERRY) SEED OIL, SYNTHETIC WAX, CAPRYLIC/CAPRIC TRIGLYCERIDE, C13-15 ALKANE, CETYL ALCOHOL, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), MICA, SILICA, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYHYDROXYSTEARIC ACID, CAPRYLYL GLYCOL, HEXYLENE GLYCOL, HAEMATOCOCCUS PLUVIALIS EXTRACT, PHENOXYETHANOL, CI 15850 (RED 7), CI 77492 (IRON OXIDES).
You May Report An Adverse Reaction To:
cosnova USA Inc 55 5th Ave. New York, NY 10003, USA.
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