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

Perfect Day 2 in 1 Everywear SPF 50 and Mint Condition Lip Shield SPF 30 by

Drug Labeling and Warnings

Perfect Day 2 in 1 Everywear SPF 50 and Mint Condition Lip Shield SPF 30 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., TAYLOR JAMES, LTD. , Cosway Company Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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 body 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: Ask a doctor

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:

• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-500

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-500-01	1 in 1 KIT	09/16/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE, WITH APPLICATOR	44 mL
Part 2	1 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 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 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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-501-01	44 mL in 1 TUBE, WITH APPLICATOR; Type 7: Separate Products Requiring Cross Labeling

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/16/2016

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-502-01	3 g in 1 APPLICATOR; Type 7: Separate Products Requiring Cross Labeling

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/16/2016

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc.		620899877	manufacture(75936-501, 75936-500)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		965596435	manufacture(75936-502, 75936-500)