JULEP NO EXCUSES GEL FOR FACE SPF40- avobenzone, homosalate, octisalate, octocrylene gel

Julep No Excuses Gel for Face SPF40 by

Drug Labeling and Warnings

Julep No Excuses Gel for Face SPF40 by is a Otc medication manufactured, distributed, or labeled by Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

JULEP NO EXCUSES GEL FOR FACE SPF40 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
UNDECANE (UNII: JV0QT00NUE)
TRIDECANE (UNII: A3LZF0L939)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MUSKMELON (UNII: ZV095H5633)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
STANNIC OXIDE (UNII: KM7N50LOS6)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-106-00	1 in 1 CARTON	01/01/2023
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2023

Labeler - Cosmax Usa, Corporation (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(68577-106)