NDC | 72344-008-02, 72344-008-06 |
Set ID | 6d5d4380-05de-504d-e053-2991aa0aa3b7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Surface Products Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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
Water, Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Hydrated Silica, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Tideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum.
- Label
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INGREDIENTS AND APPEARANCE
SURFACE SUN SHEER TOUCH SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72344-008 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 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) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) 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) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72344-008-06 177 mL in 1 TUBE; Type 0: Not a Combination Product 03/14/2018 2 NDC:72344-008-02 74 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(72344-008)