RR SPF30 SUN STICK- spf30 sun stick stick

RR SPF30 Sun Stick by

Drug Labeling and Warnings

RR SPF30 Sun Stick by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc, Tropical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.5%

Oxybenzone 6%

INSTRUCTIONS FOR USE

Uses - Helps prevent sunburn

WARNINGS

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs
• When using this product keep out of eyes. Rinse with water to remove.
• 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
• children under 6 months of age: Ask a Doctor

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:

• limit time in the sun, especially from 10am - 2pm.
• wear long sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Other Information:

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RR SPF30 SUN STICK 
spf30 sun stick stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-276
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 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-276-05	15 mL in 1 CANISTER; Type 0: Not a Combination Product	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/31/2018

Labeler - Tropical Enterprises International, Inc (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Enterprises International, Inc.		091986179	label(58418-276)