![ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/71247eca-4402-4ecf-bac6-c64d943294f7/oclipse-c-01.jpg)
| NDC | 42851-058-21 |
| Set ID | 71247eca-4402-4ecf-bac6-c64d943294f7 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- 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.
- For children under 6 months of age: 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.
- Apply to all skin exposed to the sun.
- Other information
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Inactive ingredients
Water, C12-15 Alkyl Benzoate, Squalane, Cyclopentasiloxane, Propanediol, Styrene/Acrylates Copolymer, PPG-3 Isostearyl Methyl Ether, PEG/PPG-17/6 Copolymer, Neopentyl Glycol Diheptanoate, Acrylates Copolymer, Argania Spinosa Kernel Oil, Silica, Cetearyl Alcohol, Tocopheryl Acetate, Alumina, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Ceteareth-20, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methicone, Isohexadecane, Bisabolol, PEG-8 Laurate, Caprylyl Glycol, Triethoxycaprylylsilane, Polymethyl Methacrylate, Pentylene Glycol, Chlorphenesin, Glycerin, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Erythritol, Sorbitan isostearate, Melanin, Iron Oxides, Glycine Soja (Soybean) Seed Extract, Polyglyceryl-5 Trioleate, Ethyl Ferulate, 1,2-Hexanediol, Retinyl Palmitate, Ascorbic Acid, Nephelium Lappaceum Peel Extract, Potassium Sorbate, Ethylhexylglycerin, Beta-Glucan, Sodium Benzoate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Homarine HCL, Tocopherol, Disodium Uridine Phosphate, Citric Acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 g Bottle Carton
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INGREDIENTS AND APPEARANCE
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-058 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 57 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 49 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Squalane (UNII: GW89575KF9) Cyclomethicone 5 (UNII: 0THT5PCI0R) Propanediol (UNII: 5965N8W85T) Styrene/Acrylamide Copolymer (MW 500000) (UNII: 5Z4DPO246A) PEG/PPG-17/6 Copolymer (UNII: P5QZM4T259) Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X) Argan Oil (UNII: 4V59G5UW9X) Silicon Dioxide (UNII: ETJ7Z6XBU4) Cetostearyl Alcohol (UNII: 2DMT128M1S) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Aluminum Oxide (UNII: LMI26O6933) PEG-100 Stearate (UNII: YD01N1999R) Glyceryl Monostearate (UNII: 230OU9XXE4) Phenoxyethanol (UNII: HIE492ZZ3T) Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4) Methicone (20 CST) (UNII: 6777U11MKT) Isohexadecane (UNII: 918X1OUF1E) Levomenol (UNII: 24WE03BX2T) PEG-8 Laurate (UNII: 762O8IWA10) Caprylyl Glycol (UNII: 00YIU5438U) Triethoxycaprylylsilane (UNII: LDC331P08E) Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11) Pentylene Glycol (UNII: 50C1307PZG) Chlorphenesin (UNII: I670DAL4SZ) Glycerin (UNII: PDC6A3C0OX) Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM) Sunflower Oil (UNII: 3W1JG795YI) Polysorbate 60 (UNII: CAL22UVI4M) Erythritol (UNII: RA96B954X6) Sorbitan isostearate (UNII: 01S2G2C1E4) Melanin Synthetic (Tyrosine, Peroxide) (UNII: O0CV1RMR44) Ferric Oxide Red (UNII: 1K09F3G675) Soybean (UNII: L7HT8F1ZOD) Ethyl Ferulate (UNII: 5B8915UELW) 1,2-Hexanediol (UNII: TR046Y3K1G) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Ascorbic Acid (UNII: PQ6CK8PD0R) Nephelium Lappaceum Fruit Rind (UNII: Y0513T90FO) Potassium Sorbate (UNII: 1VPU26JZZ4) Ethylhexylglycerin (UNII: 147D247K3P) Sodium Benzoate (UNII: OJ245FE5EU) Rosemary (UNII: IJ67X351P9) Homarine Hydrochloride (UNII: 8866LNG61N) Tocopherol (UNII: R0ZB2556P8) Uridine Monophosphate Disodium (UNII: KD8E20071T) Citric Acid Monohydrate (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-058-21 1 in 1 CARTON 02/01/2017 1 118 g 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 FINAL part352 02/01/2017 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 MANUFACTURE(42851-058)
