Label: EUCERIN OIL-CONTROL SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 66800-6000-1, 66800-6000-2
- Packager: Beiersdorf Inc
- 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 March 27, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
■ apply liberally 15 minutes before sun exposure
■ reapply at least every 2 hours
■ use a water resistant sunscreen if swimming or sweating
■ 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 value 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-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
Water, Alcohol Denat., Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, Polyglyceryl-6 Stearate, Sodium Stearoyl Glutamate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Behenyl Alcohol, Butylene Glycol Dicaprylate/Dicaprate, Cetearyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Dibutyl Adipate, L-Carnitine, Glycyrrhiza Inflata Root Extract, Glycyrrhetinic Acid, Tocopherol, Dimethicone, Silica Dimethyl Silylate, Diethylhexyl Syringylidenemalonate, Ethylcellulose, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Phenoxyethanol, Glycerin, Xanthan Gum, Ethylhexylglycerin, Disodium EDTA, Hydroxyacetophenone, Polyglyceryl-6 Behenate, Cetyl Alcohol, Sodium Ascorbyl Phosphate
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INGREDIENTS AND APPEARANCE
EUCERIN OIL-CONTROL SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-6000 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) LEVOCARNITINE (UNII: 0G389FZZ9M) GLYCYRRHIZA ECHINATA ROOT (UNII: V6E722P1VB) ENOXOLONE (UNII: P540XA09DR) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) COPERNICIA PRUNIFERA WHOLE (UNII: 6EKZ38572S) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) DIBUTYL ADIPATE (UNII: F4K100DXP3) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XANTHAN GUM (UNII: TTV12P4NEE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) DOCOSANOL (UNII: 9G1OE216XY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) ETHYLHEXYLGLYCERYL BEHENATE (UNII: JRY34LRD7B) DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CETYL ALCOHOL (UNII: 936JST6JCN) Product Characteristics Color white (off-white to yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-6000-1 75 g in 1 TUBE; Type 0: Not a Combination Product 11/02/2021 2 NDC:66800-6000-2 10 g in 1 TUBE; Type 0: Not a Combination Product 03/27/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/02/2021 Labeler - Beiersdorf Inc (001177906)
