Label: NU-DERM HEALTHY SKIN PROTECTION SPF 35- octinoxate and zinc oxide cream
- NDC Code(s): 62032-200-01, 62032-200-90
- Packager: OBAGI COSMECEUTICAL 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 September 3, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply 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 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-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other information
-
Inactive ingredients
butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, DEA-cetyl phosphate, disodium EDTA, ethylhexyl stearate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, sodium hydroxide, triethoxycaprylylsilane, water (aqua)
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
-
INGREDIENTS AND APPEARANCE
NU-DERM HEALTHY SKIN PROTECTION SPF 35
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 90 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) WATER (UNII: 059QF0KO0R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) METHYLPARABEN (UNII: A2I8C7HI9T) LAURETH-7 (UNII: Z95S6G8201) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLPARABEN (UNII: 3QPI1U3FV8) DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) SODIUM HYDROXIDE (UNII: 55X04QC32I) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-200-90 90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2002 03/31/2020 2 NDC:62032-200-01 1 in 1 CARTON 04/01/2020 2 85 mL in 1 BOTTLE, PLASTIC; 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 01/01/2002 Labeler - OBAGI COSMECEUTICAL LLC (790553353) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 MANUFACTURE(62032-200)