BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40- avobenzone, octisalate, octocrylene cream

Body Butter Broad Spectrum Sunscreen SPF 40 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients  Purpose

Avobenzone 3%     Sunscreen

Octisalate 5%         Suncreen

Octocrylene 10%    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
If swallowed, get medical help or contact a poison Control Center right away

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

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating

Sun Protection Measures Spending time in the sun increases your risk of
skin cancer and early skin aging. To decrease this risk, regularly use a
sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun
protection measures including: limit your time in the sun, especially from 10
a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients

Water, Isododecane, Glycerin, Trimethoxybenzylidene Pentanedione, Polyester-8, Poly C10-30 Alkyl Acrylate, Cetearyl Olivate, Oryza Sativa (Rice) Bran Extract, Sucrose Stearate, Diisopropyl Sebacate, Hydroxyacetophenone, Isodecyl Neopentanoate, Lauryl Lactate, Sodium Polyacrylate Starch, Diethylhexyl Syringlidenemalonate, Sodium Stearoyl Glutamate, C18-38 Alkyl Hydroxystearoyl Stearate, Chlorphenesin, Ethylhexylglycerin, 1,2 Hexanediol, Caprylyl Glycol, Helianthus Annuus(Sunflower) Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Tocopherol, Romarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Citric Acid, Hippophae Rhamnoides Seed Oil, Citrus Nobilis (Manadarin Orange) Peel Oil, Cymbopogon Schoenanthus Oil, Elettaria Cardamomum Seed Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Cinnamomum Cassia, Vanillin, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil

PRINCIPAL DISPLAY PANEL

Supergoop!

Body Butter

SPF 40

Broad Spectrum Sunscreen SPF 40

5.7 fl. oz./168 ml

INGREDIENTS AND APPEARANCE

BODY BUTTER BROAD SPECTRUM SUNSCREEN SPF 40 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-256
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
RICE BRAN (UNII: R60QEP13IC)
SUCROSE STEARATE (UNII: 274KW0O50M)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
LAURYL LACTATE (UNII: G5SU0BFK7O)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
MANDARIN OIL (UNII: NJO720F72R)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
CARDAMOM OIL (UNII: JM0KJ091HZ)
CLOVE LEAF OIL (UNII: VCA5491KVF)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
VANILLIN (UNII: CHI530446X)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVANDIN OIL (UNII: 9RES347CKG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-256-01	168 mL in 1 PACKAGE; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2020

Labeler - Taylor James Ltd. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company		620899877	manufacture(75936-256)