EVEN TONE AND RADIANCE CC COLOR CORRECTION SKIN PROTECTION SPF30- avobenzone, ensulizole, homosalate, octisalate, and octocrylene cream

EVEN TONE and RADIANCE by

Drug Labeling and Warnings

EVEN TONE and RADIANCE by is a Otc medication manufactured, distributed, or labeled by AHAVA Dead Sea Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone [3%]	sunscreens
Ensulizole [2%]	sunscreens
Homosalate [7%]	sunscreens
Octisalate [5%]	sunscreens
Octocrylene [0.87%]	sunscreens

Uses

• helps prevent sunburn

Warnings

For External Use Only

When using this product keep out of eyes. Rinse with water to remove

Stop use and consult a doctor if rash or irritation develops and lasts

Do not use on damaged or broken skin

Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Center right away

Directions

• apply liberally and evenly to clean face 15 minutes before sun exposure
• apply daily for a clearer, brighter complexion
• children under 6 months of age: Ask a doctor

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENTS

AQUA (MINERAL SPRING WATER), CAPRYLYL METHICONE, GLYCERIN, PROPANEDIOL (CORN DERIVED), CETYL ALCOHOL, CELLULOSE ACETATE, ORYZA SATIVA (RICE) BRAN OIL, TITANIUM DIOXIDE (CI 77891), GLYCERYL STEARATE, GALACTOARABINAN, PHENOXYETHANOL, AMINOMETHYL PROPANOL, PEG-75 STEARATE, BORON NITRIDE, DIMETHICONE, IRON OXIDES (CI 77492), CAPRYLYL GLYCOL, UREA, CETETH-20, STEARETH-20, ALLANTOIN, PARFUM (FRAGRANCE), BUTYLPHENYL METHYLPROPIONAL, LINALOOL, GERANIOL, HYDROXYCITRONELLAL, CITRONELLOL, CHLORPHENESIN, LYSOLECITHIN, SCLEROTIUM GUM, SACCHARIDE HYDROLYSATE, ACRYLATES/ AMMONIUM METHACRYLATE COPOLYMER, IRON OXIDES (CI 77491), DISODIUM EDTA, HYDROGENATED POLYDECENE, MAGNESIUM ASPARTATE, PROPYLENE GLYCOL STEARATE, XANTHAN GUM, DIMETHICONOL, IRON OXIDES (CI 77499), MAGNESIUM STEARATE, MICA, FERRIC FERROCYANIDE (CI 77510), CITRIC ACID, POTASSIUM SORBATE, SODIUM BENZOATE, CREATINE, PULLULAN, GLYCINE, ALANINE, PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT, DUNALIELLA SALINA (DEAD SEA ALGA) EXTRACT, MARIS AQUA (DEAD SEA WATER/OSMOTER).

Other information

Protect the product in this container from excessive heat and direct sun

Questions or comments

Call toll free 1-800-366-7254

SPL UNCLASSIFIED SECTION

Manufactured by AHAVA Dead Sea
Laboratories, Dead Sea, Israel, 8698000
In EU: AHAVA Cosmetics GmbH, Borsigstr. 36,
D-65205 Wiesbaden, Germany
In US: AHAVA N.A. LLC, New York, NY 10001

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

AHAVA

CC CREAM
COLOR CORRECTION
SKIN PROTECTION

BROAD SPECTRUM
SPF 30

EVEN TONE
& RADIANCE

INGREDIENTS AND APPEARANCE

EVEN TONE AND RADIANCE   CC COLOR CORRECTION SKIN PROTECTION SPF30
avobenzone, ensulizole, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.9 g  in 30 mL
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.6 g  in 30 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	2.1 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1.5 g  in 30 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.261 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL ALCOHOL (UNII: 936JST6JCN)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
RICE BRAN OIL (UNII: LZO6K1506A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GALACTOARABINAN (UNII: SL4SX1O487)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PEG-75 STEARATE (UNII: OT38R0N74H)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
UREA (UNII: 8W8T17847W)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
CHLORPHENESIN (UNII: I670DAL4SZ)
LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
INVERT SUGAR (UNII: ED959S6ACY)
FERRIC OXIDE RED (UNII: 1K09F3G675)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
PROPYLENE GLYCOL MONOSTEARATE (UNII: MZM1I680W0)
XANTHAN GUM (UNII: TTV12P4NEE)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICA (UNII: V8A1AW0880)
FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CREATINE (UNII: MU72812GK0)
PULLULAN (UNII: 8ZQ0AYU1TT)
GLYCINE (UNII: TE7660XO1C)
ALANINE (UNII: OF5P57N2ZX)
DATE (UNII: H3O7QI5HY7)

Product Characteristics
Color	WHITE (Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-287-22	1 in 1 CARTON	04/20/2020
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 NOT FINAL	part352	04/20/2020

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)