LUMIOR EMPOWERED DAY MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, homosalate, and octisalate cream

LUMIOR Empowered Day Moisturizer Broad Spectrum SPF 15 by

Drug Labeling and Warnings

LUMIOR Empowered Day Moisturizer Broad Spectrum SPF 15 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, Octyldodecyl Neopentanoate, Trehalose, HDI/Trimethylol Hexyl-lactone Crosspolymer, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Biosaccharide Gum-4, Glyceryl Stearate, Caprylyl Glycol, Methylpropanediol, Isodecyl Isononanoate, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Glycol Stearate, Myristyl Myristate, Sorbitan Tristearate, Propanediol (Corn derived), Dimethicone, Dimethiconol, Benzotriazolyl Dodecyl p-Cresol, Propylene Glycol, Silica, 1,2-Hexanediol, Lactic Acid, Ceteareth-20, Peg-40 Stearate, Parfum (Fragrance), Allantoin, Xanthan Gum, Tocopheryl (Vitamin E) Acetate, Tocopherol (Vitamin E), Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Chamomilla Recutita (Matricaria) Flower 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 every morning to a clean face and neck for recharged, protected skin
• 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

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Manufactured by AHAVA Dead Sea Laboratories, Dead Sea, Israel, 8698000

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

LUMIOR
BY AHAVA

GLOW DEFENDER

EMPOWERED DAY MOISTURIZER
BROAD SPECTRUM SPF 15

INGREDIENTS AND APPEARANCE

LUMIOR EMPOWERED DAY MOISTURIZER BROAD SPECTRUM SPF 15 
avobenzone, homosalate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-298
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
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Polyester-8 (1400 MW, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Trehalose (UNII: B8WCK70T7I)
Hexamethylene Diisocyanate/Trimethylol Hexyllactone Crosspolymer (UNII: WB5K9Y35Y9)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Biosaccharide Gum-4 (UNII: 9XRL057X90)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Caprylyl Glycol (UNII: 00YIU5438U)
Methylpropanediol (UNII: N8F53B3R4R)
Isodecyl Isononanoate (UNII: 4X46Q4U00Z)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Glycol Stearate (UNII: 0324G66D0E)
Myristyl Myristate (UNII: 4042ZC00DY)
Sorbitan Tristearate (UNII: 6LUM696811)
Dimethicone (UNII: 92RU3N3Y1O)
Allantoin (UNII: 344S277G0Z)
Propylene Glycol (UNII: 6DC9Q167V3)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Peg-40 Stearate (UNII: ECU18C66Q7)
Chamomile (UNII: FGL3685T2X)
Olive Oil (UNII: 6UYK2W1W1E)
Simmondsia Chinensis Seed (UNII: D24K2Q1F6H)
Xanthan Gum (UNII: TTV12P4NEE)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Benzotriazolyl Dodecyl p-Cresol (UNII: 298PX4M11X)
Tocopherol (UNII: R0ZB2556P8)
Sodium Chloride (UNII: 451W47IQ8X)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
1,2-Hexanediol (UNII: TR046Y3K1G)
Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-298-24	1 in 1 CARTON	02/01/2021
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	02/01/2021

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)