Label: DEARDERM DAILY MOSITURE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72279-078-01 - Packager: RAINBOW BEAUTY COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 21, 2020
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Directions
- Other Information
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Inactive Ingredients
Water (Aqua), Stearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate (and) Peg-100 Stearate, Ethylhexyl Palmitate, Dimethicone, Paraffinum Liquidum, Phenoxyethanol, Aloe Barbadensis Leaf Juice, PVP, Menthone Glycerin Acetal, Triethanolamine, Carbomer, Fragrance, PEG-8, Disodium EDTA, Ethylhexylglycerin, Tocopheryl Acetate, Retinyl Palmitate.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
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INGREDIENTS AND APPEARANCE
DEARDERM DAILY MOSITURE SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72279-078 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 150 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 24 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Cetyl Alcohol (UNII: 936JST6JCN) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72279-078-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/01/2018 Labeler - RAINBOW BEAUTY COMPANY (012749151) Establishment Name Address ID/FEI Business Operations Samson Pharmaceuticals Inc. 088169581 MANUFACTURE(72279-078)