Label: SS-TMPFL- bs spf30 spray - dl spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 58418-001-01, 58418-001-02, 58418-001-04, 58418-001-08, view more58418-001-10, 58418-001-12, 58418-001-16, 58418-001-25, 58418-001-28, 58418-001-32, 58418-001-64, 58418-001-70 - Packager: Tropical Enterprises International, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 8, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE AND ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
-
WARNINGS
WARNINGS: Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer and early skin aging.
For external use only.
When using this product avoid contact with eyes. If contact with eyes occurs, flush with water to remove.
Stop use and ask a doctor if irritation or rash develops and persists.
- ACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SS-TMPFL
bs spf30 spray - dl sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1.98 g in 30 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.7425 g in 30 mL Inactive Ingredients Ingredient Name Strength ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58418-001-10 10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/01/2018 2 NDC:58418-001-01 30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/01/2018 3 NDC:58418-001-02 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/01/2018 4 NDC:58418-001-04 120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/01/2018 5 NDC:58418-001-12 360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2018 6 NDC:58418-001-08 240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 10/01/2018 7 NDC:58418-001-16 480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2018 8 NDC:58418-001-64 1920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2018 9 NDC:58418-001-28 3840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2018 10 NDC:58418-001-70 211200 mL in 1 DRUM; Type 0: Not a Combination Product 10/01/2018 11 NDC:58418-001-32 1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 10/01/2018 12 NDC:58418-001-25 960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 04/24/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2018 Labeler - Tropical Enterprises International, Inc. (091986179) Registrant - Tropical Enterprises International, Inc. (091986179) Establishment Name Address ID/FEI Business Operations Tropiical Enterprises International, Inc. 091986179 manufacture(58418-001) , label(58418-001) , pack(58418-001)
