SUN-DEFYING SUNSCREEN OIL BROAD SPECTRUM SPF 50 SUPERGOOP- avobenzone, homosalate, octisalate, octocrylene, octinoxate oil

Sun-Defying Sunscreen Oil Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun-Defying Sunscreen Oil Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 15% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 7% Sunscreen

Octinoxate 7.5 % Sunscreen

PURPOSE

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

Keep out of reach of children

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating

· Reapply at least every 2 hours

· 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 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-sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Octyl Dodecanol, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, SD Alcohol 40-B, Ethylenediamine/Hydrogenated Dimer Dilinoleate Copolymer Bis-Di-C14-18 Alkyl Amide, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Alaria Esculenta Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocotrienol, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Punica Granatum Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Citrus Limon (Lemon) Peel Extract, Calendula Officinalis Flower Extract

PRINCIPAL DISPLAY PANEL

Supergoop!

Sun-Defying Sunscreen oil with Meadowfoam

Broad Spectrum SPF 50

5 Fl. Oz. / 148 ml

INGREDIENTS AND APPEARANCE

SUN-DEFYING SUNSCREEN OIL BROAD SPECTRUM SPF 50  SUPERGOOP
avobenzone, homosalate, octisalate, octocrylene, octinoxate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-125
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	15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LAURYL LACTATE (UNII: G5SU0BFK7O)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
GRAPE SEED OIL (UNII: 930MLC8XGG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
ARGAN OIL (UNII: 4V59G5UW9X)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
POMEGRANATE (UNII: 56687D1Z4D)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
ORANGE PEEL (UNII: TI9T76XD44)
TANGERINE PEEL (UNII: JU3D414057)
LEMON PEEL (UNII: 72O054U628)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-125-02	1 in 1 BOX	12/03/2013
1	NDC: 75936-125-01	148 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 75936-125-04	1 in 1 BOX	12/03/2013
2	NDC: 75936-125-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 75936-125-06	1 in 1 BOX	12/03/2013
3	NDC: 75936-125-05	10 mL in 1 BOTTLE; 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	12/03/2013

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-125)