Label: ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30- titanium dioxide and zinc oxide cream
- NDC Code(s): 42851-060-15, 42851-060-30, 42851-060-75
- Packager: ZO Skin Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure and as needed.
- Use a water-resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months: Ask a doctor.
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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 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.
- Other Information
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Inactive Ingredients
Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone,Dimethicone/Vinyl DimethiconeCrosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Extract, Ecklonia Kurome Extract, Glycine Soja (Soybean) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract,
Hexyl Laurate, Polyglyceryl-4 Isostearate, Tribehenin, Bisabolol, Cetyl PEG/PPG-10/1 Dimethicone,Water, Glycerin, Squalane, Polymethyl Methacrylate, Dimethiconol, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Caprylyl Glycol, Behenyl Behenate, Melanin, Tocopheryl Acetate, Ethyl Ferulate, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Ethylhexylglycerin, Tocopherol,
Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-060 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 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERRIC OXIDE RED (UNII: 1K09F3G675) ALUMINUM OXIDE (UNII: LMI26O6933) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K) SUNFLOWER OIL (UNII: 3W1JG795YI) CENTELLA ASIATICA LEAF (UNII: 6810070TYD) ECKLONIA KUROME (UNII: 802YF989GT) SOYBEAN (UNII: L7HT8F1ZOD) ROSEMARY (UNII: IJ67X351P9) HEXYL LAURATE (UNII: 4CG9F9W01Q) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) TRIBEHENIN (UNII: 8OC9U7TQZ0) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BEHENYL BEHENATE (UNII: K8NU647RJ0) ETHYL FERULATE (UNII: 5B8915UELW) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ASCORBIC ACID (UNII: PQ6CK8PD0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) LEVOMENOL (UNII: 24WE03BX2T) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-060-15 1 in 1 CARTON 10/31/2019 1 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:42851-060-30 1 in 1 CARTON 10/31/2019 2 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:42851-060-75 1 in 1 CARTON 10/31/2019 3 75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/31/2019 Labeler - ZO Skin Health, Inc. (826468527)