SUNSCREEN MIST BROAD SPECTRUM SPF 30 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate, octocrylene spray

Sunscreen Mist Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sunscreen Mist Broad Spectrum SPF 30 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 Flamamble. 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

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 10 a.m.-2p.m.

wear long-sleved shirts, pants, hats, and sunglasses

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, Helianthus Annuus (Sunflower) Seed Oil, Isodecyl Neoppentanoate, Lavandula Angustifolia (lavender) Oil, Mentha Piperita (Peppermint Oil) Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (Vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Coploymer, Vitis Vinifera (Grape) Seed Oil.

PRINCIPAL DISPLAY PANEL

Supergoop! Antioxidant-infused

Sunscreen Mist

with Vitamin C

Broad Spectrum SPF 30

Water resistant (80 minutes)

apply to wet or dry skin

Twist-lock cap

6 fl. oz./177 ml

INGREDIENTS AND APPEARANCE

SUNSCREEN MIST BROAD SPECTRUM SPF 30  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-123
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: 75936-123-01	177 mL in 1 CAN; Type 0: Not a Combination Product	01/07/2013
2	NDC: 75936-123-03	1 in 1 PACKAGE	01/07/2013
2	NDC: 75936-123-02	89 mL in 1 CAN; 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	01/07/2013

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Bell International Laboratories		967781555	manufacture(75936-123)