EVERYDAY SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate lotion

Everyday Sunscreen SPF 50 by

Drug Labeling and Warnings

Everyday Sunscreen 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 10%       Sunscreen

Octinoxate 7.5%        Sunscreen

Octisalate 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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

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 to face and and body at least 15 minutes prior to sun exposure. water resistant

INACTIVE INGREDIENT

Inactive Ingredients Water, Isododecane, Polyester-8, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Potassium Cetyl Phosphate, Phenoxyethanol, Cetearyl alcohol, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Diethylhexyl, Syringylidenemalonate, Acrylates Copolymer, Cetyl Alcohol, Beheneyl Alcohol, Ethylhexylglycerin, Glyceryl Stearate, Chlorpehensin, Xanthan Gum, Caprylyl Glycol, Palmitic Acid, Stearic Acid, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Lauryl Alcohol, Myristyl Alcohol, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Limonene, Allantoin, Disodium EDTA, Thermus Thermophillus Ferment, Lecithin, Pentylene Glycol, Panthenol, Sodium Hydroxide, BHT, Cassia Alata Leaf Extract, Maltodextrin, Gernaniol, Citral, 1,2-Hexandiol, Beta Glucan, Citric Acid, Sodium Benzoate, Tocopheryl, Potassium Sorbate

PRINCIPAL DISPLAY PANEL

Supergoop Play

SPF 50

Water Resistant (80 minutes)

Everyday Sunscreen with cellular response technology

Broad Spectrum SPF 50

Oil-free, face & body lotion protects from sun's rays, defending skin from photoaging

and dehydration

2.4 Fl. Oz. / 71 ml

INGREDIENTS AND APPEARANCE

EVERYDAY SUNSCREEN SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-135
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAURYL LACTATE (UNII: G5SU0BFK7O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
CETYL ALCOHOL (UNII: 936JST6JCN)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
BEHENIC ACID (UNII: H390488X0A)
CETYL BEHENATE (UNII: WFM51TRO3E)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
LAURYL ALCOHOL (UNII: 178A96NLP2)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
ROSEWOOD OIL (UNII: F2522O5L7B)
ORANGE OIL (UNII: AKN3KSD11B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
POGOSTEMON CABLIN TOP (UNII: 2I2A73IYL7)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE SODIUM (UNII: MP1J8420LU)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
GERANIOL (UNII: L837108USY)
CITRAL (UNII: T7EU0O9VPP)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-135-02	1 in 1 CARTON	01/20/2015
1	NDC: 75936-135-01	71 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75936-135-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2015
3	NDC: 75936-135-04	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2015
4	NDC: 75936-135-05	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2015
5	NDC: 75936-135-06	3 mL in 1 PACKET; Type 0: Not a Combination Product	01/20/2015
6	NDC: 75936-135-07	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/20/2015

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company, Inc.		620899877	manufacture(75936-135)