NDC | 58418-276-05 |
Set ID | 7496c1a5-c31b-10c0-e053-2991aa0aa359 |
Category | HUMAN OTC DRUG LABEL |
Packager | Tropical Enterprises International, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- INSTRUCTIONS FOR USE
- WARNINGS
-
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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RR SPF30 SUN STICK
spf30 sun stick stickProduct 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)