PERFECT DAY 2 IN 1 EVERYWEAR SPF 50 AND MINT CONDITION LIP SHIELD SPF 30 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate 
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.

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Perfect Day 2-in-1 Broad Spectrum Sunscreen Everywear Lotion SPF 50 + Mint Condition Lip Shield SPF 30

Lotion

Active Ingredients                    Purpose

Avobenzone 3% ...................... Sunscreen

Homosalate 10% ..................... Sunscreen

Octinoxate 7.5% ...................... Sunscreen

Octisalate 5% .......................... Sunscreen

Lip Shield

Active Ingredients                     Purpose

Avobenzone 2% ...................... Sunscreen

Homosalate 15% ..................... Sunscreen

Octinoxate 7.5% ...................... Sunscreen

Octisalate 5% .......................... Sunscreen

Uses

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings

Directions


Suns Protection Measures  Spending time in the sun increases your risk of skin cancer an early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and take other sun protection measures including:

Lotion

Water, Isododecane, Polyester-8, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Potassium Cetyl Phosphate, Phenoxyethanol, Cetearyl Alcohol, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Ammonium Acyloyldimethyltaurate/VP Copolymer, Diethylhexyl Syringylidenemalonate, Acyrlates Copolymer, Cetyl Alcohol, Behenyl Alcohol, Ethyhexylglycerin, Glyceryl Stearate, Chlorphenesin, Xanthan Gum, Caprylyl Glycol, Pamitic Acid, Stearic Acid, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Lauryl Alcohol, Myristyl Alcohol, Aniba Rosaedora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cabin Oil, Limonene, Allantoin, Disodium EDTA, Thermus Thermophillus Ferment, Lecithin, Pentylene Glycol, Panthenol, Sodium Hydorxide, BHT, Cassia Alata Leaf Extract, Maltodextrin, 1,2-Hexanediol, Beta-Glucan, Citric Acid, Sodium Benzoate, Tocopherol, Potassium Sorbate

Lip Shield

Coera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Helianthus Anuus (Sunflower) Seed Oil, Tocopherol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Mint Flavor, Lanolin, Stevia Rebaudiana, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Rosmarinus Officinalis (Rosemary) Leaf Extract, Vitis Vinifera (Grape) Seed Oil

Perfect Day 2-in-1

Everywear Lotion  + Mint Codnitions Lipshield

Broad Spectrum Sunscreen SPF 50/ SPF 30

1.5 fl. oz. / 44 ml

0.07oz / 3g

tube

kit

Cap

PERFECT DAY 2 IN 1 EVERYWEAR SPF 50 AND MINT CONDITION LIP SHIELD SPF 30  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-500
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-500-011 in 1 KIT09/16/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE, WITH APPLICATOR 44 mL
Part 21 APPLICATOR 3 g
Part 1 of 2
EVERYWEAR SPF 50  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate cream
Product Information
Item Code (Source)NDC:75936-501
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 1.5) (UNII: V2W71V8T0X)  
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)  
LEMON OIL (UNII: I9GRO824LL)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
PATCHOULI OIL (UNII: F3IN55X5PO)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
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)  
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:75936-501-0144 mL in 1 TUBE, WITH APPLICATOR; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/16/2016
Part 2 of 2
MINT CONDITION LIP SHIELD SPF 30  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate lipstick
Product Information
Item Code (Source)NDC:75936-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX (UNII: 7G1J5DA97F)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
JOJOBA OIL (UNII: 724GKU717M)  
LANOLIN (UNII: 7EV65EAW6H)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
SOYBEAN OIL (UNII: 241ATL177A)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ROSEMARY (UNII: IJ67X351P9)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-502-013 g in 1 APPLICATOR; Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/16/2016
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company Inc.620899877manufacture(75936-501, 75936-500)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC965596435manufacture(75936-502, 75936-500)

Revised: 1/2017
Document Id: 831a8743-e6f8-443f-98d9-9f559e6dfd1e
Set id: 0211dad6-87b0-46ca-9321-0fe68257aa29
Version: 3
Effective Time: 20170116
 
TAYLOR JAMES, LTD.