- PURPOSE
- Active ingredients
- Directions
- WARNING AND Pracaution
- ASK DOCTOR SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
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INACTIVE INGREDIENT
ingredients: water, propylene glycol,
polyurethane-34, cetyl alcohol, potassium cetyl
phosphate, glycerin, sorbitan mono stearate,
polysorbate 60, phenoxyethanol,
ethylhexylglycerin, potassium hydroxide,
dimethicone, tocopheryl acetate, acrylates/C10-
30 alkyl acrylate crosspolymer, arginine, sodium
ascorbyl phosphate, disodium EDTA - Product Label
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF50
avobenzone , homosalate , octisalate , oxybenzone , octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72376-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 117 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 54 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 45 mg in 1 g Inactive Ingredients Ingredient Name Strength Propylene glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF) Cetyl alcohol (UNII: 936JST6JCN) Potassium cetyl phosphate (UNII: 03KCY6P7UT) Glycerin (UNII: PDC6A3C0OX) Sorbitan monostearate (UNII: NVZ4I0H58X) Polysorbate 60 (UNII: CAL22UVI4M) Phenoxyethanol (UNII: HIE492ZZ3T) Ethylhexylglycerin (UNII: 147D247K3P) Potassium hydroxide (UNII: WZH3C48M4T) Dimethicone (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) Arginine (UNII: 94ZLA3W45F) Sodium ascorbyl phosphate (UNII: 836SJG51DR) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72376-001-01 51 g in 1 BOTTLE; Type 0: Not a Combination Product 06/11/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/11/2018 Labeler - SKIN KIDZ CC (538908603) Establishment Name Address ID/FEI Business Operations SKIN KIDZ CC 538908603 manufacture(72376-001)