EVERYDAY SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate lotion 
TAYLOR JAMES, LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Everyday Broad Spectrum SPF 50

Active Ingredients      Purpose

Avobenzone 3%         Sunscreen                   

Homosalate 10%       Sunscreen

Octinoxate 7.5%        Sunscreen

Octisalate 5%            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

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

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

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

Secondary Art

Primary Art

EVERYDAY SUNSCREEN SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-135-021 in 1 CARTON01/20/2015
1NDC:75936-135-0171 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:75936-135-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
3NDC:75936-135-04222 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
4NDC:75936-135-05532 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
5NDC:75936-135-063 mL in 1 PACKET; Type 0: Not a Combination Product01/20/2015
6NDC:75936-135-0710 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2015
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company, Inc.620899877manufacture(75936-135)

Revised: 1/2017
Document Id: 3bb571a8-4e7c-4431-ab8e-f797560be9f6
Set id: dbc8bc52-f974-4662-8353-de7e73d5979a
Version: 4
Effective Time: 20170105
 
TAYLOR JAMES, LTD.