BEAUTY COUNTER PROTECT ALL OVER SUNSCREEN SPF30- zinc oxide emulsion

Beauty Counter Protect All over Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

Warnings

For external use only

Do not use

On damaged or broken skin

Stop use and ask a doctor if

rash occures or irritation develops and lasts

When using this product

Keep out of eyes.  Rinse with water to remove

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: Ask a doctor
• reapply:  After 40 minues of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun protection measures.  Spending time in the sun increases you risk of skin cancer and early skin aging.  To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long sleeved shirts, pants, hats and sunglasses.

Other information

• Protect the product in this container from excessive hear and direct sun
• store at temperature below 90°C

Inactive Ingredients

1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Aloe Barbadensis Leaf Extract, Beeswax, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Nonanoate, Chamomilla Recutita Flower Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Limon (Lemon) Oil, Citus Mobilis (Mandarin Orange) oil, Citrus Reticulata (Tangarine) Oil, Citrus Sinensis (Blood Orange) Fruit Extract, Coco-caprylate, Decylene Glycol, Ethylhexyl Palmitate, Glycerin, Hydrogenated Castor Oil, Isopropyl Myristate, Isopropyl Palmitate, Isostearic Acid, Lecithin, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Mimosa Tenuiflora Bark Extract, Phenoxyethanol, Polyglyceryl-3 PolyricinoleatePolyglyceryl-4 Diisostearate/Polyhydroxystearate?Sebacate, Polyhydroxystearic Acid, Silica, Sodium Chloride, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEAUTY COUNTER PROTECT ALL OVER SUNSCREEN  SPF30
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69026-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETEARYL NONANOATE (UNII: F6ZWV2F361)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
ORANGE OIL (UNII: AKN3KSD11B)
LEMON OIL (UNII: I9GRO824LL)
MANDARIN OIL (UNII: NJO720F72R)
CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)
CITRUS SINENSIS FRUIT, IMMATURE (UNII: 1WSB6777D4)
COCO-CAPRYLATE (UNII: 4828G836N6)
DECYLENE GLYCOL (UNII: S57M60MI88)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARIC ACID (UNII: X33R8U0062)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PEPPERMINT OIL (UNII: AV092KU4JH)
MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69026-253-01	142 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2014

Labeler - Counter Brands LLC (079400401)