SKIN CRAVE SPF15 LIP BALM- spf15 lip balm (chemical) lipstick 
Tropical Enterprises International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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spf15 lip balm

Active Ingredients: Purpose: Sunscreen

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

Purpose: Sunscreen

Uses: Helps prevent sunburn

Warnings:

Stop use and ask a doctor if rash occurs.

Directions:

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

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

Questions or Comments? 1-877-773-9800

PLPD

SKIN CRAVE SPF15 LIP BALM 
spf15 lip balm (chemical) lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-295
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 mg  in 15 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 15 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 15 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM, GRAPE, CITRUS, CHERRY, STRAWBERRY, BERRY, MINT, PEPPERMINT, VANILLA, WATERMELON, TROPICAL FRUIT PUNCH, POMEGRANATE, ROOT BEER, MANGO, COCONUTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-295-1515 mL in 1 CANISTER; Type 0: Not a Combination Product08/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2012
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose083819404manufacture(58418-295)

Revised: 7/2018
Document Id: 70bbafcd-0992-71b9-e053-2991aa0a2422
Set id: 484dcd16-27c2-1113-e054-00144ff8d46c
Version: 3
Effective Time: 20180711
 
Tropical Enterprises International, Inc.