SKIN CRAVE SPF15 LIP BALM (spf15 lip balm- chemical lipstick

Skin Crave spf15 lip balm by

Drug Labeling and Warnings

Skin Crave spf15 lip balm by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc., Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Purpose: Sunscreen

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses: Helps prevent sunburn

WARNINGS

Warnings:

• Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. Thois product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only
• Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

WHEN USING

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

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.

INSTRUCTIONS FOR USE

Directions:

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

INACTIVE INGREDIENT

Inactive Ingredients: Sunflower oil, beeswax, extra virgin olive oil, flavor, hemp seed oil, rosemaruy extract, vitamin E, aloe vera

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive heat and direct sun.

QUESTIONS

Questions or Comments? 1-877-773-9800

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SKIN CRAVE SPF15 LIP BALM 
spf15 lip balm (chemical) lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 15 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 15 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 15 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM, GRAPE, CITRUS, CHERRY, STRAWBERRY, BERRY, MINT, PEPPERMINT, VANILLA, WATERMELON, TROPICAL FRUIT PUNCH, POMEGRANATE, ROOT BEER, MANGO, COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-295-15	15 mL in 1 CANISTER; Type 0: Not a Combination Product	08/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2012

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	manufacture(58418-295)