ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30- homosalate, octisalate, avobenzone, and octocrylene lotion

enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

enfuselle BODY SUNSCREEN BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Shaklee Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active ingredients

Homosalate 10%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%

Purpose

Sunscreen

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

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure.
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and 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.
• children under 6 months: Ask a doctor

Inactive ingredients:

Water/Eau, Butyloctyl Salicylate,
C12-15 Alkyl Benzoate, Cetyl
PEG/PPG-10/1 Dimethicone,
Cyclopentasiloxane, Microcrystalline
Wax, Cetyl Dimethicone,
Cyclohexasiloxane, Panthenol,
Tocopheryl Acetate, Magnesium
Ascorbyl Phosphate, Beta-Glucan,
Retinyl Palmitate, Vitis Vinifera (Grape)
Seed Extract, Superoxide Dismutase,
Glycerin, Hydrogenated Castor Oil,
Ethylhexylglycerin, Phenyl
Trimethicone, Caprylyl Glycol,
Polyglyceryl-4 Isostearate, Hexyl
Laurate, Sodium Chloride, Silica,
Disodium EDTA, Phenoxyethanol

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

925.734.3638

PRINCIPAL DISPLAY PANEL CARTON

WATER RESISTANT

PARABEN FREE

4 fl. oz. 118 mL

              All Skin Types

Multipatented formula provides
broad-spectrum SPF 30 protection from
sun’s harmful rays to help reduce the
risk of skin damage. Regular use of this
product may help minimize visible
lines, uneven coloration, dryness, and
dullness associated with sun exposure.
Triple patented Vital Repair+ Complex®
helps disarm free radicals, which can
create prematurely older-looking skin.
Quickly absorbed lotion locks in
moisture without leaving a sticky finish.
Ideal for sensitive skin.

Contains triple patented
Vital Repair+ Complex®
Water resistant (80 minutes)
Designed not to clog pores
100% fragrance and
paraben free
Allergy tested
Clinically formulated
Dermatologist tested
Patented sensitive-skin
formula
Not tested on animals

Dist. by/par Shaklee Corporation
4747 Willow Road
Pleasanton, CA 94588 USA
Item #32565
Imp. by/par Shaklee Canada Inc.
3100 Harvester Road, Unit 7
Burlington, ON L7N 3W8

PRINCIPAL DISPLAY PANEL TUBE

Broad-spectrum SPF 30 protection helps shield skin from
sun’s harmful rays. 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.

Directions: Apply generously 15 minutes before
sun exposure.

INGREDIENTS AND APPEARANCE

ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 
homosalate, octisalate, avobenzone, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59899-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59899-007-01	1 in 1 CARTON	11/11/2013
1		118 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/11/2013

Labeler - Shaklee Corporation (020284076)