Label: PERFECT DAY 2 IN 1 EVERYWEAR SPF 50 AND MINT CONDITION LIP SHIELD SPF 30 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-500-01, 75936-501-01, 75936-502-01 - Packager: TAYLOR JAMES, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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INGREDIENTS AND APPEARANCE
PERFECT DAY 2 IN 1 EVERYWEAR SPF 50 AND MINT CONDITION LIP SHIELD SPF 30 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate kitProduct 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 creamProduct 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 lipstickProduct 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)
