NDC | 62032-121-90 |
Set ID | 63e387a7-13b1-417e-a042-d33c1ddbb1f7 |
Category | HUMAN OTC DRUG LABEL |
Packager | OMP, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
-
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. Children under 6 months: Ask a doctor.
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.
-
Inactive ingredients
1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Label
-
INGREDIENTS AND APPEARANCE
OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-121 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 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 105 mg in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) PEG-40 STEARATE (UNII: ECU18C66Q7) SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TROPOLONE (UNII: 7L6DL16P1T) CHLORPHENESIN (UNII: I670DAL4SZ) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) UBIDECARENONE (UNII: EJ27X76M46) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-121-90 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/07/2012 Labeler - OMP, Inc. (790553353) Establishment Name Address ID/FEI Business Operations MILBAR LABORATORIES 195556790 MANUFACTURE(62032-121)