Label: SURFACE SUN DRY TOUCH SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72344-009-03, 72344-009-06 - 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 30, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Keep Out of Reach of Children.
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Directions
Apply liberally 15 minutes before sun exposure. Reapply:
- after 80 minutes of swimming or 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-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months: ask a doctor.
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Inactive Ingredients
1,2-Hexanediol, Behenyl Alcohol, BHT, Butyloctyl Salicylate, Calcium Pantothenate, Caprylyl Glycol, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrated Silica, Lecithin, Lepidium Sativum Sprout Extract, Maltodextrin, Niacinamide, PEG-100 Stearate, Polyester-8, Pyridoxine HCl, Silica, Sodium Ascorbyl Phosphate, Sodium Polyacrylate, Sodium Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.
- Label
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INGREDIENTS AND APPEARANCE
SURFACE SUN DRY TOUCH SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-009 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 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) TRIDECETH-6 (UNII: 3T5PCR2H0C) XANTHAN GUM (UNII: TTV12P4NEE) ACRYLIC ACID (UNII: J94PBK7X8S) TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYDRATED SILICA (UNII: Y6O7T4G8P9) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) ALLANTOIN CALCIUM PANTOTHENATE (UNII: SM1342S52N) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) MALTODEXTRIN (UNII: 7CVR7L4A2D) NIACINAMIDE (UNII: 25X51I8RD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72344-009-06 177 mL in 1 TUBE; Type 0: Not a Combination Product 03/14/2018 2 NDC:72344-009-03 88.7 mL in 1 TUBE; 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(72344-009)
