LUMIOR EXCLUSIVE DAY BROAD SPECTRUM SPF 20- avobenzone, homosalate, and octisalate cream

LUMIOR by

Drug Labeling and Warnings

LUMIOR 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
Homosalate [7%]	sunscreens
Octisalate [5%]	sunscreens

Inactive ingredients

Aqua (Mineral Spring Water), Butyloctyl Salicylate, Polyester-8, Trehalose, Propanediol (Corn derived), Octyldodecyl Neopentanoate, Cyclopentasiloxane, Glycerin, Butylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Glyceryl Stearate, Sorbitan Tristearate, Myristyl Myristate, Glycol Stearate, Phenoxyethanol, PEG-40 Stearate, Silica, Dimethicone, Allantoin, Parfum (Fragrance), Benzyl Salicylate, Limonene, Hexyl Cinnamal, Linalool, Citronellol, Hydroxycitronellal, Benzyl Benzoate, Alpha Isomethyl Ionone, Hydroxyethylcellulose, Xanthan Gum, Sorbitan Laurate, Ceteareth-20, Propylene Glycol, Methyl Methacrylate Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Benzotriazolyl Dodecyl p-Cresol, Dimethiconol, Illite, Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Cyclodextrin, Sodium Benzoate, Potassium Sorbate, Hydrolyzed Corn Protein, Linum Usitatissimum (Linseed) Seed Extract, Tocopheryl (Vitamin E) Acetate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Mentha Piperita (Peppermint) Leaf Juice, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Acetyl Dipeptide-1 Cetyl Ester, Palmitoyl Tripeptide-38, Pichia Ferment Lysate Filtrate, Sea Silt (Dead Sea Mud) Extract, Maris Aqua (Dead Sea Mineral Elixir).

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 Centre right away

Directions

• apply each morning to clean face and neck. Embrace your radiance
• 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

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 US: AHAVA N.A. LLC, New York, NY 10001

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

LUMIOR
BY AHAVA

ETERNAL

EXCLUSIVE DAY CREAM
BROAD SPECTRUM SPF 20

CRÈME DE JOUR EXCLUSIVE
SPF 20

INGREDIENTS AND APPEARANCE

LUMIOR   EXCLUSIVE DAY BROAD SPECTRUM SPF 20
avobenzone, homosalate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-295
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	70 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
TREHALOSE (UNII: B8WCK70T7I)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCOL STEARATE (UNII: 0324G66D0E)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
LEDIKITE (UNII: D7BC5B0F46)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
BENZYL BENZOATE (UNII: N863NB338G)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
COUMARIN (UNII: A4VZ22K1WT)
GERANIOL (UNII: L837108USY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
FLAX SEED (UNII: 4110YT348C)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-295-24	1 in 1 CARTON	10/01/2020
1		50 mL in 1 JAR; 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	10/01/2020

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)