LUMIOR MEN FACIAL MOISTURIZER BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene lotion

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%]	sunscreen
Octisalate [5%]	sunscreen
Octocrylene [2.74%]	sunscreen

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 Contol Center right away

Directions

• apply every morning to a clean face. Fortify your skin!
• use a water-resistant sunscreen if swimming or sweating.
• reapply at least every 2 hours.
• 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), BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, GLYCERIN, PEG-40 STEARATE, SORBITAN TRISTEARATE, DIMETHICONE, NYLON 6/12, OCTYLDODECYL NEOPENTANOATE, CETEARYL OLIVATE, SORBITAN OLIVATE, CYCLOMETHICONE, PHENOXYETHANOL, CETYL PALMITATE, CETYL PHOSPHATE, SORBITAN PALMITATE, DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES, ISOSTEARYL ISOSTEARATE, BISABOLOL, UREA, POTASSIUM SORBATE, SODIUM BENZOATE, BENZOIC ACID, QUATERNIUM-18 HECTORITE, PROPANEDIOL, SACCHARIDE HYDROLYSATE, PVP, ETHYLHEXYLGLYCERIN, LACTIC ACID, XANTHAN GUM, PROPYLENE CARBONATE, BETA-SITOSTEROL, HYDROGENATED VEGETABLE GLYCERIDES CITRATE, PARFUM (FRAGRANCE), LINALOOL, LIMONENE, ALPHA ISOMETHYL IONONE, FARNESOL, COUMARIN, EUGENOL, BENZYL SALICYLATE, SALICYLIC ACID, 1,2-HEXANEDIOL, ASCORBYL PALMITATE, CREATINE, CAPRYLYL GLYCOL, DEHYDROACETIC ACID, SODIUM HYDROXIDE, LECITHIN, PROPYLENE GLYCOL, PSEUDOALTEROMONAS FERMENT EXTRACT, ALANINE, GLYCINE, MAGNESIUM ASPARTATE, TOCOPHEROL (VITAMIN E), PANTHENOL (PRO VITAMIN B5), OPUNTIA FICUS-INDICA FRUIT EXTRACT, PANAX GINSENG ROOT EXTRACT, ALLANTOIN, PORPHYRA UMBILICALIS (ALGA) EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SPROUT EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, COMMIPHORA ABYSSINICA (MYRRH) RESIN EXTRACT, SANGUISORBA OFFICINALIS (GREAT BURNET) ROOT EXTRACT, CINNAMOMUM CASSIA (CHINESE CINNAMON) BARK EXTRACT, SQUALENE (PLANT SQUALENE), GINKGO BILOBA LEAF EXTRACT, ALOE BARBADENSIS (ALOE-VERA) LEAF JUICE, SODIUM (HYALURONIC ACID SALT) HYALURONATE, MARIS AQUA (DEAD SEA MINERAL ELIXIR).

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 Bottle Carton

LUMIOR
BY AHAVA

FORTIFY

MEN FACIAL MOISTURIZER
BROAD SPECTRUM SPF 15

INGREDIENTS AND APPEARANCE

LUMIOR   MEN FACIAL MOISTURIZER BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-296
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
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETYL PHOSPHATE (UNII: VT07D6X67O)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
LEVOMENOL (UNII: 24WE03BX2T)
UREA (UNII: 8W8T17847W)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZOIC ACID (UNII: 8SKN0B0MIM)
QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX)
PROPANEDIOL (UNII: 5965N8W85T)
INVERT SUGAR (UNII: ED959S6ACY)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
FARNESOL (UNII: EB41QIU6JL)
COUMARIN (UNII: A4VZ22K1WT)
EUGENOL (UNII: 3T8H1794QW)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
SALICYLIC ACID (UNII: O414PZ4LPZ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CREATINE (UNII: MU72812GK0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALANINE (UNII: OF5P57N2ZX)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ALLANTOIN (UNII: 344S277G0Z)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CUCUMBER (UNII: YY7C30VXJT)
GINGER (UNII: C5529G5JPQ)
MYRRH (UNII: JC71GJ1F3L)
CHINESE CINNAMON (UNII: WS4CQ062KM)
GINKGO (UNII: 19FUJ2C58T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60289-296-24	1 in 1 CARTON	10/01/2020
1		50 mL in 1 BOTTLE, GLASS; 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)