MINERAL RADIANCE ENERGIZING DAY BS SPF 15- avobenzone, homosalate, and octisalate cream

Mineral Radiance Energizing Day BS SPF 15 by

Drug Labeling and Warnings

Mineral Radiance Energizing Day BS 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

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), 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 Leaf Juice, Glycol Stearate, Myristyl Myristate, Sorbitan Tristearate, Propanediol (Corn derived Glycol), Dimethicone, Dimethiconol, Allantoin, Propylene Glycol, Ceteareth-20, Peg-40 Stearate, Chamomilla Recutita (Matricaria) Flower Extract, Parfum (Fragrance), Olea Europaea (Olive) Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Extract, Xanthan Gum, Tocopheryl (Vitamin E) Acetate, Benzotriazolyl Dodecyl p-Cresol, Tocopherol (Vitamin E), Maris Aqua (Dead Sea Water), Silica, 1,2 Hexanediol, Lactic Acid.

Other information

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

Questions or comments

Call toll free 1-800-366-7254

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

AHAVA

MINERAL RADIANCE
Energy Radiance Protection

Energizing Day Cream
Broad Spectrum SPF15

50 ml e 1.7 fl.oz

INGREDIENTS AND APPEARANCE

MINERAL RADIANCE ENERGIZING DAY BS SPF 15 
avobenzone, homosalate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60289-284
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: 60289-284-24	1 in 1 CARTON	11/15/2016
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 FINAL	part352	11/15/2016

Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)