NDC | 72344-006-06 |
Set ID | 6ccc1c4f-906f-17d1-e053-2991aa0a4c6a |
Category | HUMAN OTC DRUG LABEL |
Packager | Surface Products Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Use
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Warnings
For external use only.
Flammable: do not use near heat, flame, or while smoking. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Keep away from face to avoid breathing it. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F. Stop use and ask a doctor if rash occurs.
- Keep Out of Reach of Children.
-
Directions
Spray liberally and evenly by hand 15 minutes before sun exposure.
Reapply after:
80 minutes of sweating or swimming
immediately after towel drying
at least every 2 hoursHold can 4-6 inches from the skin to apply. Do not spray directly into your face. Spray on hands an then apply to face. Do not apply in windy conditions. Use in a well-ventilated area.
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-sleeved shirts, pants, hats, and sunglasses.Children under 6 months: ask a doctor.
- Inactive Ingredients
- Label
-
INGREDIENTS AND APPEARANCE
SURFACE SUN WETSKIN FORMULA SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ALCOHOL (UNII: 3K9958V90M) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) POLYESTER-7 (UNII: 0841698D2F) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72344-006-06 170 mL in 1 CAN; Type 0: Not a Combination Product 03/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/14/2018 Labeler - Surface Products Corp (010777036) Registrant - CGI Packaging, LLC (080691099) Establishment Name Address ID/FEI Business Operations CGI Packaging, LLC 080691099 manufacture(72344-006)