Label: CREAM- octinoxate, zinc oxide cream
- NDC Code(s): 61354-070-04, 61354-070-08
- Packager: Oxygen Development LLC
- 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 February 10, 2023
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- Official Label (Printer Friendly)
- active ingredients
- purpose
- uses
- warnings
- do not use
- when using
- stop use
- keep out of reach of children
- directions
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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 at least 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am - 2pm
- wear long-sleeved shirts, pants, hats, and sunglasses
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inactive ingredients
water (aqua/eau), Acetamidoethoxyethanol, Tridecyl Trimellitate, Octyldodecyl Neopentanoate, polysilicone-31, niacinimide, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Butylene Glycol, Aluminum Starch Octenylsuccinate, Caprylyl Methicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Isohexadecane, mica, Potassium Cetyl Phosphate, Peg-8 Dimethicone, PEG-100 Stearate, Glyceryl Stearate, glycerin, yeast extract, xanthan gum, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxycaprylylsilane, polysorbate 80, soy amino acids, Ethylhexylglycerin, Tetrahexyldecyl Ascorbate, Arnica Montana Flower Extract.
- other information
- package label - primary
- package label - secondary
-
INGREDIENTS AND APPEARANCE
CREAM
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) PHENOXYETHANOL (UNII: HIE492ZZ3T) ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR) POLYSILICONE-15 (UNII: F8DRP5BB29) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) ISOHEXADECANE (UNII: 918X1OUF1E) PEG-8 DIMETHICONE (UNII: GIA7T764OD) WATER (UNII: 059QF0KO0R) PEG-100 STEARATE (UNII: YD01N1999R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NIACINAMIDE (UNII: 25X51I8RD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-070-08 1 in 1 CARTON 02/22/2021 02/10/2023 1 NDC:61354-070-04 40 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/22/2021 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-070)