BEAUTY COUNTER DEW SKIN MOISTURIZER DARK SPF 20- zinc oxide lotion

Beauty Counter Dew Skin Moisturizer Dark by

Drug Labeling and Warnings

Beauty Counter Dew Skin Moisturizer Dark by is a Otc medication manufactured, distributed, or labeled by Counter Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide - 14%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• if used as directed witho other sun production measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and aks a doctor

if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor.
• Sun Protection Measures

Spending time in the sun increases you risk of skin cancer and early skin aging.  To decrease this risk, regularly  use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10AM-2PM
• Wear long sleeved shirts, pants, hats and sunglasses
• Reapply at leat every 2 hours
• Use a water resistant sunscreen if swimming or sweating.

Other Information

• Store at temperatures below 90°F.
• Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Water, Caprylic/Capric Triglyceride, Coc-Caprylate, Trimethylsiloxysilicate, Isoprpyl Palmitate, Dimethicone/Vinyl Dimethicone Crosspolymer, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Palmitate, Isoproyl Myristate, Octyldodecyl Oleate, Dimethicone, Magnesium Sulfate, Beeswax, Glucolactone, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Sodium Hyaluronate, Sodium Chloride, Glycerin, Propanediol, Sodium Benzoate, Isoeicosane, Hydrogenated Castor Oil, Tetrahexyldecyl Ascorbate, Ribes Nigrum (Black Currant) Seed Oil, Octyldodecanol, Octyldodecyl Stearoyl Stearate,  Alcohol, Paeonia Suffruticosa (Peony) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Solidago Virgqurea (Goldenrod) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Citrus Aurantium Dulcis (Orange) Oil, Rosa Damascena (Rose) Flower Oil, Salvia Sclarea (Clary) Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Vanilla Planifolia Fruit Extract, Silica, Titanium Dioxide, Iron Oxides, Mica.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEAUTY COUNTER DEW SKIN MOISTURIZER DARK  SPF 20
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69026-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
YELLOW WAX (UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
ORANGE OIL (UNII: AKN3KSD11B)
COCO-CAPRYLATE (UNII: 4828G836N6)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOEICOSANE (UNII: AR294KAG3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
OCTYLDODECANOL (UNII: 461N1O614Y)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
ALMOND OIL (UNII: 66YXD4DKO9)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
ROSEMARY (UNII: IJ67X351P9)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
VANILLA (UNII: Q74T35078H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69026-282-02	1 in 1 CARTON	04/01/2015
1	NDC: 69026-282-01	40 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	04/01/2015

Labeler - Counter Brands, LLC (079400401)