SUNSCREEN MIST BROAD SPECTRUM SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate, octocrylene spray

Sunscreen Mist Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sunscreen Mist Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Bell International Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose
Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 10% Sunscreen

Uses Helps prevent sunburn

If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings Flammable. Keep away from flames and sparks

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.

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

Directions

Apply liberally 15 minutes before sun exposure

Reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours when exposed to sunlight

Children under 6 months: Ask a doctor

Inactive Ingredients Alcohol Denat , Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

PRINCIPAL DISPLAY PANEL

Water resistant (80 minutes)

Apply to wet or dry skin

twist-lock cap

SPF 50 sunscreen

Antioxidant-Infused

Sunscreen Mist

with Vitamin C

Broad Spectrum

INGREDIENTS AND APPEARANCE

SUNSCREEN MIST BROAD SPECTRUM SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CANANGA OIL (UNII: 8YOY78GNNX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
LIME OIL (UNII: UZH29XGA8G)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
MANDARIN OIL (UNII: NJO720F72R)
ORANGE OIL TERPENELESS (UNII: L8B7EWV9I7)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ACAI (UNII: 46AM2VJ0AW)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAVENDER OIL (UNII: ZBP1YXW0H8)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
GRAPE SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-124-02	1 in 1 PACKAGE	01/29/2013
1	NDC: 75936-124-01	177 mL in 1 CAN; Type 0: Not a Combination Product
2	NDC: 75936-124-03	89 mL in 1 CAN; Type 0: Not a Combination Product	01/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/29/2013

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(75936-124)