![PANAMA JACK BROAD SPECTRUM SPF 100 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING INC.]](https://medic.hrt.org//dailymed/images/67500b02-6c91-3d10-e053-2991aa0ac295/13630-0124-4.jpg)
| NDC | 13630-0124-4 |
| Set ID | 67500b02-6c91-3d10-e053-2991aa0ac295 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Packaging Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product keep out of eyes. Risne with water to remove.
Keep away from face to avoid breathing it. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120ºF.
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Directions
- Spray liberally and spread evenly by hand 15 minutes before sun exposure.
- Hold container 4 to 6 inches from the skin to apply.
- Do not spray directly into face. Spray on hands then apply to face.
- Do not apply in windy conditions.
- Use in well ventilated areas.
- Reapply:
- after 80 minutes of swimming and sweating.
- immediately after towel drying.
- at least every 2 hours.
- 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 of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Inactive Ingredients
- Other Information
- Question or comments?
- Panama Jack 100 Broad Spectrum SPF 100 Sunscreen
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INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 100 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 26.28 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 131.4 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 43.8 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 87.6 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 52.56 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALCOHOL (UNII: 3K9958V90M) VINYL ACETATE (UNII: L9MK238N77) MONOBUTYL MALEATE (UNII: F2LD7FVO1L) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0124-4 177 mL in 1 CAN; Type 0: Not a Combination Product 01/24/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/24/2018 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0124) , analysis(13630-0124) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 label(13630-0124) , pack(13630-0124)
