Label: CREAM- zinc oxide cream
- NDC Code(s): 61354-089-01
- 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 2, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- When using
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirt, pants, hat, and sunglasses. Children under 6 months: ask a doctor
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Inactive ingredient
Water/Aqua, C15-19 Alkane, Glycerin, Polyglyceryl-3 Polyricinoleate, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Styrene/Acrylates Copolymer, Stearyl/Octyldodecyl Citrate Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, 1,2-Hexanediol, Hydroxyacetophenone, Magnesium Sulfate, Sodium Chloride, Caprylhydroxamic Acid, Tocopheryl Acetate, Sodium Hyaluronate, Tocopherol, Malic Acid
- Other information
- Package label
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INGREDIENTS AND APPEARANCE
CREAM
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-089 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.05 mg in 100 mg Inactive Ingredients Ingredient Name Strength 1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.9 mg in 100 mg HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) 0.5 mg in 100 mg MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 0.5 mg in 100 mg WATER (UNII: 059QF0KO0R) 31.495 mg in 100 mg STYRENE (UNII: 44LJ2U959V) 2.91 mg in 100 mg PROPANEDIOL (UNII: 5965N8W85T) 1.95 mg in 100 mg SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.5 mg in 100 mg STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) 2 mg in 100 mg MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3 mg in 100 mg LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) 1.99 mg in 100 mg POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) 1 mg in 100 mg TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.95 mg in 100 mg ETHYL MACADAMIATE (UNII: ANA2NCS6V1) 3.99 mg in 100 mg C15-19 ALKANE (UNII: CI87N1IM01) 15 mg in 100 mg POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) 4 mg in 100 mg GLYCERIN (UNII: PDC6A3C0OX) 4.98 mg in 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-089-01 1 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/02/2023 Labeler - Oxygen Development LLC (137098492) Establishment Name Address ID/FEI Business Operations Oxygen Development LLC 137098492 manufacture(61354-089)
