FOREVER SUN LIPS- sunscreen lipstick

Forever Sun Lips by

Drug Labeling and Warnings

Forever Sun Lips by is a Otc medication manufactured, distributed, or labeled by Aloe Vera of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Avobenzone 3.0%..................: Sunscreen
• Homosalate 10.0%................: Sunscreen
• Octisalate 5.0%.....................: Sunscreen
• Octocrylene 2.79%................: Sunscreen
• Petrolatum 38%....................: Lip Protectant

Uses

• helps prevent and temporarily protects chapped or cracked lips
• helps prevent and protect from the drying effects of wind and cold weather
• 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 and broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask 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 this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Inactive ingredients

glycine soja (soybean) oil, ozokerite, butyloctyl salicylate, flavor, beeswax, ethylhexyl hydroxystearate, euphorbia cerifera (candelilla) wax, simmondsia chinensis (jojoba) seed oil, copernicia cerifera (carnauba) wax, menthol, menthyl lactate, aloe barbadensis leaf extract, allantoin

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Call 1-888-440-2563

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOREVER SUN LIPS 
sunscreen lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11697-462
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.1275 g  in 4.25 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.4250 g  in 4.25 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.2125 g  in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1186 g  in 4.25 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	1.6150 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)	.4473 g  in 4.25 g
CERESIN (UNII: Q1LS2UJO3A)	.3868 g  in 4.25 g
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)	.2295 g  in 4.25 g
YELLOW WAX (UNII: 2ZA36H0S2V)	.1275 g  in 4.25 g
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)	.1148 g  in 4.25 g
CANDELILLA WAX (UNII: WL0328HX19)	.1063 g  in 4.25 g
JOJOBA OIL (UNII: 724GKU717M)	.0850 g  in 4.25 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	.0425 g  in 4.25 g
MENTHOL (UNII: L7T10EIP3A)	.0223 g  in 4.25 g
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)	.0223 g  in 4.25 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	.0138 g  in 4.25 g
ALLANTOIN (UNII: 344S277G0Z)	.0004 g  in 4.25 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11697-462-03	12 in 1 BOX
1	NDC: 11697-462-02	1 in 1 CARTON
1	NDC: 11697-462-01	4.25 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/25/2014

Labeler - Aloe Vera of America, Inc. (049049463)

Establishment
Name	Address	ID/FEI	Business Operations
Aloe Vera of America, Inc.		049049463	manufacture(11697-462)