BEAUTY COUNTER PROTECT LIP SPF15- zinc oxide lipstick

Beauty Counter Protect Lip by

Drug Labeling and Warnings

Beauty Counter Protect Lip by is a Otc medication manufactured, distributed, or labeled by Beauty Counter, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide - 8.05%

Purpose

  Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see ​Directions​), decreases the rist 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 reach of children

Stop use and ask a doctor if

• Rash occurs

Keep out of reach of children.

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

Directions

• Apply Liberally 15 minutes before sun exposure.
• Children under 6 months: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 a Broad Spectrum SPF value 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
•    After 80 minutes of swimming or sweating
•    Immediately after towel drying
•    At least every 2 hours.

Other Information

• Protect the product in this container from excessive heat and direct sun
• Store at room temperatures below 90 degrees Fahrenheit.

Inactive Ingredients

Aloe Barbadenis (Aloe Vera) Leaf Extract, Beeswax, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Carthamux Tinctorius (Safflower) Seed Oil, Cetearyl Nonanoate, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis Peel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Cucurbita Pepo (Pumpkin) Seed Oil, Euterpe Oleracea Fruit Oil,
Heliantus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Mica, Olea Europaea (Olive) Fruit Oil, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Squalane, Stevia Rebaudiana Leaf/Stem Powder, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Tribehenin, Vanilla Planifolia Fruit

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEAUTY COUNTER PROTECT LIP  SPF15
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69026-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	8.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
ORANGE OIL (UNII: AKN3KSD11B)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
MANDARIN OIL (UNII: NJO720F72R)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOSTEARIC ACID (UNII: X33R8U0062)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MICA (UNII: V8A1AW0880)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
ROSEMARY OIL (UNII: 8LGU7VM393)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SQUALANE (UNII: GW89575KF9)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69026-287-01	4.75 g in 1 CYLINDER; Type 0: Not a Combination Product	12/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/15/2015

Labeler - Counter Brands, LLC (079400401)