Julep No Excuses Gel For Face Spf40

Julep No Excuses Gel For Face Spf40
SPL v5
SPL
SPL Set ID 298404c4-d4be-7395-e063-6294a90a86bf
Route
TOPICAL
Published
Effective Date 2023-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (80 mg) Octisalate (50 mg) Octocrylene (26 mg)
Inactive Ingredients
Water Caprylyl Trisiloxane Dipropylene Glycol Butyloctyl Salicylate Undecane Tridecane Caprylyl Glycol Phenoxyethanol Rosa Canina Fruit Oil Ammonium Acryloyldimethyltaurate/vp Copolymer Carbomer Homopolymer, Unspecified Type Camellia Japonica Seed Oil Dibutyl Lauroyl Glutamide Dibutyl Ethylhexanoyl Glutamide Aminomethylpropanol Glycerin Glycyrrhizinate Dipotassium .alpha.-tocopherol Acetate Edetate Disodium Anhydrous Mica Butylene Glycol Pentylene Glycol Hydroxyphenyl Propamidobenzoic Acid Ferric Oxide Red Titanium Dioxide Muskmelon 1,2-hexanediol Stannic Oxide Tocopherol Sunflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

AVOBENZONE 3% HOMOSALATE 8% OCTISALATE 5% OCTOCRYLENE 2.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% HOMOSALATE 8% OCTISALATE 5% OCTOCRYLENE 2.6%

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.

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.

Do Not Use

on damaged or broken skin.

Drug Facts

Other Information

Protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 8%

OCTISALATE 5%

OCTOCRYLENE 2.6%

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.

Questions Or Comments?

Call 877-651-3292

Stop Use and Ask Doctor

if rash occurs.

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of the Reach of Children.

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


Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

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.

Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Other Information

Protect this product from excessive heat and direct sun.

Package Labeling:

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 8%

OCTISALATE 5%

OCTOCRYLENE 2.6%

Inactive Ingredients (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.

Questions Or Comments? (Questions or Comments?)

Call 877-651-3292

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

if rash occurs.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

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


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Raw Label Data

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