Label: OBAGI-C RX SYSTEM SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN- octinoxate and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 62032-121-90 - Packager: OMP, Inc.
- 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 December 19, 2012
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- Active ingredients
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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
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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.
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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
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Label
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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)