Label: SURFACE SUN DRY TOUCH SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 72344-005-06 - Packager: Surface Products Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 May 23, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
-
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 DRY TOUCH SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-005 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 15 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72344-005-06 170 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(72344-005)
