NDC | 58418-275-05 |
Set ID | 747f1399-7397-3d26-e053-2991aa0a9df3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Tropical Enterprises International, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- 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, reguarly 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 10a.m. - 2p.m.
- wear long sleeved shirts, pants, hats and sunglasses
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FT SPF30 SUN STICK
spf30 sun stick - ft stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-275 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WHITE WAX (UNII: 7G1J5DA97F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PARAFFIN (UNII: I9O0E3H2ZE) ETHYLHEXYL PALMITATE (UNII: 2865993309) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) ASCORBIC ACID (UNII: PQ6CK8PD0R) CANDELILLA WAX (UNII: WL0328HX19) CETYL ALCOHOL (UNII: 936JST6JCN) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CERESIN (UNII: Q1LS2UJO3A) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58418-275-05 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(58418-275)