NDC | 72667-005-01 |
Set ID | 7cb0c15d-ee93-4d78-e053-2a91aa0aea1c |
Category | HUMAN OTC DRUG LABEL |
Packager | Inspec Solutions LLC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- WARNINGS
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
Behenyl Alcohol
BHT
Butyloctyl Salocylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Fragrance
Glyceryl Stearate
Hydrated Silicia
PEG-100 Stearate
Phenoxyethanol
Polyester-8
Sodium Polyacrylate
Styrene/ Acrylate Copolymer
Trideceth-6
Trimethylsiloxysilicate
VP/Hexadecene Copolyer
Water
Xanthan Gum
- STOP USE
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SURFACE SHEER TOUCH SPF 50 WITH FRAGRANCE
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72667-005 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 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 Inactive Ingredients Ingredient Name Strength DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI) DOCOSANOL (UNII: 9G1OE216XY) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE 20 (UNII: H8YMB5QY0D) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) HYDRATED SILICA (UNII: Y6O7T4G8P9) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIDECETH-6 (UNII: 3T5PCR2H0C) XANTHAN GUM (UNII: TTV12P4NEE) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) STYRENE (UNII: 44LJ2U959V) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) WATER (UNII: 059QF0KO0R) 4-METHYL-1,4-PENTANEDIYL DIMETHACRYLATE (UNII: 3BHT04VYO9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72667-005-01 177 mL in 1 TUBE; Type 0: Not a Combination Product 12/10/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/10/2018 Labeler - Inspec Solutions LLC. (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC. 081030372 manufacture(72667-005)