Label: OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 50 BY SUZANOBAGIMD- titanium dioxide and zinc oxide cream
- NDC Code(s): 62032-608-35
- Packager: Obagi Cosmeceuticals 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 May 4, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a physician
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Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Cetearyl Alcohol, Dimethicone, Propanediol, Polyhydroxystearic Acid, Cetearyl Glucoside, Aloe Barbadensis Leaf Extract, Brassica Oleracea Italica (Broccoli) Extract, Bioflavonoids, Dipotassium Glycyrrhizate, Polyglyceryl- 2, Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Sodium C14-16 Olefin Sulfonate Stearic Acid, Lauryl Glucoside, Triethoxycaprylylsilane, Xanthan Gum, Silica, Alumina, Caprylhydroxamic Acid, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499)
- Other Information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 96.3 g Tube Carton
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INGREDIENTS AND APPEARANCE
OBAGI MEDICAL PHYSICAL DEFENSE BROAD SPECTRUM MINERAL SUNSCREEN SPF 50 BY SUZANOBAGIMD
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 58 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 144 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Dicaprylyl Carbonate (UNII: 609A3V1SUA) Glycerin (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Dimethicone (UNII: 92RU3N3Y1O) Propanediol (UNII: 5965N8W85T) Cetearyl Glucoside (UNII: 09FUA47KNA) ALOE VERA LEAF (UNII: ZY81Z83H0X) Broccoli (UNII: UOI4FT57BZ) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Lauryl Glucoside (UNII: 76LN7P7UCU) Triethoxycaprylylsilane (UNII: LDC331P08E) Xanthan Gum (UNII: TTV12P4NEE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) Caprylhydroxamic Acid (UNII: UPY805K99W) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-608-35 1 in 1 CARTON 04/01/2020 1 96.3 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 FINAL part352 04/01/2020 Labeler - Obagi Cosmeceuticals LLC (790553353) Establishment Name Address ID/FEI Business Operations G.S.COSMECEUTICAL USA 017014734 MANUFACTURE(62032-608)