![URBAN OUTFITTERS SPF 15 BROAD SPECTRUM SUNSCREEN (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING INC.]](https://medic.hrt.org//dailymed/images/68184cc8-ee46-4207-e053-2a91aa0aac79/13630-0127-4.jpg)
| NDC | 13630-0127-4 |
| Set ID | 68184cc8-ee46-4207-e053-2a91aa0aac79 |
| 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
- Question or comments?
- Urban Outfitters Sunscreen Continuous Spray 15 Broad Spectrum SPF 15
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INGREDIENTS AND APPEARANCE
URBAN OUTFITTERS SPF 15 BROAD SPECTRUM SUNSCREEN
avobenzone, octisalate, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 14.99 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) GLYCERIN (UNII: PDC6A3C0OX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VINYL ACETATE (UNII: L9MK238N77) WATER (UNII: 059QF0KO0R) DIBUTYL MALEATE (UNII: 4X371TMK9K) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color yellow (Colorless to Pale Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0127-4 177 mL in 1 CAN; Type 0: Not a Combination Product 02/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/08/2018 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc 101946028 manufacture(13630-0127) , analysis(13630-0127) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0127) , label(13630-0127)
