SUPER POWER SUNSCREEN MOUSSE SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate cream

Super Power Sunscreen Mousse SPF 50 by

Drug Labeling and Warnings

Super Power Sunscreen Mousse SPF 50 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., United Laboratories Manufacturing, LLC. 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

PURPOSE

​Uses

Helps prevent sunburn

• If used as directed with other sun protection measures (see Direction), 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.

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

DOSAGE & ADMINISTRATION

​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
• Children under 6 months: Ask a doctor

​Sun Protection Measures ​Spending time in teh 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. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fuit Extract, Bis-Hydroxyethoxypropyl Dimethicone, Butter Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Cananga Odorata Flower Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera (Cocnut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Arabica (Coffee) Seed Extract, Crambe Maritima Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrofluorocarbon 152A, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rubus Idaeus (Raspberry) Fruit Extract, Santalum Album (Sandalwood) Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water

PRINCIPAL DISPLAY PANEL

Super Power

Sunscreen

MOUSSE

Broad Spectrum SPF 50

Water resistant (80 minutes)

Supergoop!

7.1 fl. oz. / 200 mL

INGREDIENTS AND APPEARANCE

SUPER POWER SUNSCREEN MOUSSE SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-505
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PINEAPPLE (UNII: 2A88ZO081O)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
ORANGE PEEL (UNII: TI9T76XD44)
GRAPEFRUIT (UNII: O82C39RR8C)
LEMON PEEL (UNII: 72O054U628)
COCONUT (UNII: 3RT3536DHY)
COCONUT OIL (UNII: Q9L0O73W7L)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B)
CANTALOUPE (UNII: 8QF5D5H6UH)
CUCUMBER (UNII: YY7C30VXJT)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
OLIVE OIL (UNII: 6UYK2W1W1E)
PANTHENOL (UNII: WV9CM0O67Z)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ALMOND OIL (UNII: 66YXD4DKO9)
ALMOND (UNII: 3Z252A2K9G)
APRICOT (UNII: 269CJD5GZ9)
APPLE (UNII: B423VGH5S9)
RASPBERRY (UNII: 4N14V5R27W)
SANDALWOOD (UNII: 3641YW25N2)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
TREHALOSE (UNII: B8WCK70T7I)
VANILLA (UNII: Q74T35078H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-505-02	1 in 1 BOX	01/13/2017
1	NDC: 75936-505-01	100 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-505-06	1 in 1 BOX	02/07/2018
2	NDC: 75936-505-05	50 mL in 1 CAN; Type 0: Not a Combination Product
3	NDC: 75936-505-04	1 in 1 BOX	01/13/2017
3	NDC: 75936-505-03	210 mL in 1 TUBE; 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	01/13/2017

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
United Laboratories Manufacturing, LLC		807878116	manufacture(75936-505)