Label: PANOXYL OIL CONTROL MOISTURIZER- titanium dioxide and zinc oxide lotion
- NDC Code(s): 0316-0263-02
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 13, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn and photodamage caused by UVA/UVB exposure
- Higher SPF gives more sunburn protection
- If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
• Shake well prior to use
• Apply liberally to dry skin 15 minutes before sun exposure
• For topical use only
• Keep out of reach of children • 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.
• Reapply to dry skin: • At least every 2 hours • Use a water resistant suscreen if swimming for sweating
- Other Information
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Inactive Ingredients
Alumina, Aluminum Starch Octenylsucciante, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia Sinensis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Isostearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Polyhydroxystearic Acid, Purified Water, Sodium Hyaluronate, Triethoxycaprylylsilane
- Questions ?
- PanOxyl Oil Control Moisturizer 1.7oz Tube
- PanOxyl Oil Control Moisturizer 1.7oz Carton
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INGREDIENTS AND APPEARANCE
PANOXYL OIL CONTROL MOISTURIZER
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-0263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 83.4 mg in 1 g Inactive Ingredients Ingredient Name Strength GREEN TEA LEAF (UNII: W2ZU1RY8B0) YELLOW WAX (UNII: 2ZA36H0S2V) CAFFEINE (UNII: 3G6A5W338E) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) ALUMINUM STEARATE (UNII: U6XF9NP8HM) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALUMINUM OXIDE (UNII: LMI26O6933) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CYCLOMETHICONE (UNII: NMQ347994Z) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0263-02 1 in 1 CARTON 03/09/2021 1 48 g 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 not final part352 03/09/2021 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-0263)