ENFUSELLE LIP TREATMENT SPF 15 BROAD SPECTRUM- octisalate, avobenzone, and octocrylene stick

Enfuselle Lip Treatment SPF 15 Broad Spectrum by

Drug Labeling and Warnings

Enfuselle Lip Treatment SPF 15 Broad Spectrum 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

OCTISALATE 5.0%, OCTOCRYLENE 5%, AVOBENZONE 3%

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 40 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:

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, HYDROGENATED COCO-GLYCERIDES, BIS-DIGLYCERYL POLYACYLADIPATE-2, BEESWAX, OLEYL ERUCATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, HYDROGENATED OLIVE OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO (COCOA) SEED BUTTER, OLEA EUROPAEA OLIVE FRUIT OIL, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES, FRAGRANCE (PARFUM).

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

925.734.3638

PRINCIPAL DISPLAY PANEL CARTON

LIP TREATMENT
BROAD SPECTRUM SPF 15
SUNSCREEN
PARABEN FREE

Net 0.15 oz. 4 g

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

Item #32563

PRINCIPAL DISPLAY PANEL CYCLINDER

Directions: Apply generously 15 minutes before
sun exposure.

INGREDIENTS AND APPEARANCE

ENFUSELLE LIP TREATMENT SPF 15 BROAD SPECTRUM 
octisalate, avobenzone, and octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59899-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLEYL ERUCATE (UNII: 753W099NQ6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
BLACK OLIVE (UNII: 2M6QWV94OC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59899-006-01	1 in 1 CARTON	11/11/2013
1		4 g in 1 CYLINDER; 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)