Essence Pout Protector Spf 20 Lip Balm

Essence Pout Protector Spf 20 Lip Balm
SPL v1
SPL
SPL Set ID 17e483c5-6e47-9a50-e063-6394a90aa604
Route
TOPICAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (65 mg) Homosalate (73 mg) Octisalate (50 mg)
Inactive Ingredients
D&c Red No. 7 Ferric Oxide Yellow Shea Butter Haematococcus Pluvialis Cetyl Alcohol Silicon Dioxide Caprylyl Glycol Candelilla Wax Hexylene Glycol Raspberry Seed Oil Synthetic Wax (1200 Mw) Castor Oil Bis-diglyceryl Polyacyladipate-1 Carnauba Wax Mica Sunflower Oil Polyhydroxystearic Acid (2300 Mw) Phenoxyethanol Medium-chain Triglycerides C13-15 Alkane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Homosalate 7.3% Octisalate 5.0% Zinc Oxide 6.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 7.3% Octisalate 5.0% Zinc Oxide 6.5%

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.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
Do Not Use

on damaged or broken skin.

Other Information

Protect this product from excessive heat and direct sun.

Product Packaging

Active Ingredients

Homosalate 7.3%

Octisalate 5.0%

Zinc Oxide 6.5%

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).

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.

You May Report An Adverse Reaction To:

cosnova USA Inc 55 5th Ave. New York, NY 10003, USA.


Structured Label Content

Uses
  • Helps prevent sunburn.
Purpose

Sunscreen

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.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Product Packaging

Active Ingredients

Homosalate 7.3%

Octisalate 5.0%

Zinc Oxide 6.5%

Inactive Ingredients (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).

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.

You May Report An Adverse Reaction To: (You may report an adverse reaction to:)

cosnova USA Inc 55 5th Ave. New York, NY 10003, USA.


Advanced Ingredient Data


Raw Label Data

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