FOREVER YOUNG BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate cream

Forever Young Body Butter Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

Forever Young Body Butter Broad Spectrum Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Taylor James Ltd, Taylor James Ltd , Cosway Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient ................. Purpose

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

Homosalat 7.5 %................ Sunscreen

Otinoxate 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 prodcut 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 body at least 15 minutes prior to sune exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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, hates, and sunglasses

INACTIVE INGREDIENT

Water, Isononyl Isononanoate, Caprylyl Methicone, Dicaprylyl Ether, Polyester-8, Demthicone, Glycerin, Propanediol, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sorbitan Stearate, Phenoxyethanol, Pyrus Mallus (Apple) Fruit Extract, Potassium Cetyl Phosphate, Ceteareth-20, Sodium Polyactylate, Starch, Diethylhexyl Syringylidenemalonate, Sodium PCA, Hydrogenated Palm Glycerides, Ethylhexyglycerin, Chlorphenesin, Sodium Ascorbyl Glucoside, Butylene Glycol, Disodium EDTA, Trimethylcyclohexyl Butylcarbamate, Xanthan Gum, Citrus Tangerina (Tangerine) Peel Oil, Cymbopogon Shoenanthus Oil, Elettaria Cardamomum Seed Oil, Eucalyptus Globulus Leaf Oil, Eugenia Caryophylus (Clove) Flower Oil, Lavandula Hyrvida Oil, Vanilli, Limonene, Polygonum Aviculare Extract, BHT, Citral, Hippophae Rhamnoides Fruit Extract, Maltodextrin, Portulaca Oleracea Extract, Potassium Sorbate, Sodium Benzoate, Tocopherol.  

PRINCIPAL DISPLAY PANEL

Forever Young

Body Butter

With Sea Buckthorn

Broad Spectrum Sunscreen SPF 40

5.7 fl. oz. /168 ml.

INGREDIENTS AND APPEARANCE

FOREVER YOUNG BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40  SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-139
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	7.5 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)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
APPLE (UNII: B423VGH5S9)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STARCH, CORN (UNII: O8232NY3SJ)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
MANDARIN OIL (UNII: NJO720F72R)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
CARDAMOM OIL (UNII: JM0KJ091HZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CLOVE OIL (UNII: 578389D6D0)
LAVANDIN OIL (UNII: 9RES347CKG)
VANILLA (UNII: Q74T35078H)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PURSLANE (UNII: M6S840WXG5)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-139-02	1 in 1 BOX	05/13/2015
1	NDC: 75936-139-01	168 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 75936-139-03	71 mL in 1 TUBE; Type 0: Not a Combination Product	07/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/13/2015

Labeler - Taylor James Ltd (033381850)

Registrant - Taylor James Ltd (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-139)