RR SPF30 SUN STICK- spf30 sun stick stick 
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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Raining_Broad Spectrum Spf30 Sunstick 276

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.5%

Oxybenzone 6%

Uses - Helps prevent sunburn

Directions:

Apply liberally 15 minutes before sun exposure

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 value of 15 or higher and other sun protection measures including:

Beeswax, cetyl alcohol, cocoa butter, coconut oil, dimethicone, jojoba oil, ozokerite wax, rosemary extract, vitamin E

Other Information:

Protect this product from excessive heat and direct sun.

BSSPF30SUNSTICK

RR SPF30 SUN STICK 
spf30 sun stick stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-276
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCOA BUTTER (UNII: 512OYT1CRR)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
JOJOBA OIL (UNII: 724GKU717M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CERESIN (UNII: Q1LS2UJO3A)  
ROSEMARY (UNII: IJ67X351P9)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-276-0515 mL in 1 CANISTER; Type 0: Not a Combination Product08/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/31/2018
Labeler - Tropical Enterprises International, Inc (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Enterprises International, Inc.091986179label(58418-276)

Revised: 2/2020
Document Id: 9da4bf1e-24bc-59a2-e053-2a95a90a3967
Set id: 7496c1a5-c31b-10c0-e053-2991aa0aa359
Version: 2
Effective Time: 20200202
 
Tropical Enterprises International, Inc