![SUNTONE FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING INC.]](https://medic.hrt.org//dailymed/images/686bf17c-26e0-de09-e053-2a91aa0a39cb/13630-0129-4.jpg)
| NDC | 13630-0129-4 |
| Set ID | 686bf17c-26e0-de09-e053-2a91aa0a39cb |
| 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. Rinse 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 120°F.
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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 a well-ventilated area
- 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 snscreen 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
- Questions or comments?
- Suntone Sport Sunscreen Continuous Spray Broad Spectrum SPF 30
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INGREDIENTS AND APPEARANCE
SUNTONE FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 24.9 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 22.83 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 16.6 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) DIBUTYL MALEATE (UNII: 4X371TMK9K) ALCOHOL (UNII: 3K9958V90M) VINYL ACETATE (UNII: L9MK238N77) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) Product Characteristics Color yellow (Colorless to light yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0129-4 177 mL in 1 CAN; Type 0: Not a Combination Product 04/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/16/2018 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0129) , analysis(13630-0129) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0129) , label(13630-0129)
