Julep No Excuses Gel For Face Spf40 Gel
FDA Label NDC 68577-106

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 Julep No Excuses Gel For Face Spf40 (NDC 68577-106). 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 8%
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 product is swallowed, get medical help or contact a Poison Control center right away.

Directions

For sunscreen use:

• Apply liberally 15 minutes before sun exposure.

• 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 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeve shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Inactive Ingredients

WATER, CAPRYLYL METHICONE, DIPROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, DEXTRIN PALMITATE, UNDECANE, HYDROLYZED WHEAT PROTEIN/PVP CROSSPOLYMER, TRIDECANE, CAPRYLYL GLYCOL, PHENOXYETHANOL, ROSA CANINA (ROSEHIP) FRUIT OIL, AMMONIUM

ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, CARBOMER, CAMELLIA JAPONICA (TSUBAKI) SEED OIL, DIBUTYL LAUROYL GLUTAMIDE, DIBUTYL

ETHYLHEXANOYL GLUTAMIDE, AMINOMETHYL PROPANOL, GLYCERIN, DIPOTASSIUM GLYCYRRHIZATE, TOCOPHERYL ACETATE (VITAMIN E), DISODIUM EDTA, MICA (CI 77019), BUTYLENE GLYCOL, PENTYLENE GLYCOL, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, IRON OXIDES ( CI 77491), OXALIS TRIANGULARIS (LOVE PLANT) EXTRACT, TITANIUM DIOXIDE (CI 77891), CUCUMIS MELO (MELON) FRUIT EXTRACT, 1,2-HEXANEDIOL, TIN OXIDE, TOCOPHEROL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL.

Other Information

Protect this product from excessive heat and direct sun.

Questions Or Comments?

Call 877-651-3292

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