![OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/603b9b99-ece1-4aed-bf76-fffa93a1489f/oclipse-01.jpg)
| NDC | 42851-051-01, 42851-051-03 |
| Set ID | 603b9b99-ece1-4aed-bf76-fffa93a1489f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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.
- 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. - Apply to all skin exposed to the sun.
- Other information
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Inactive ingredients
Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Myristoyl Pentapeptide-8, Dimethiconol, Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 102 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 37 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) TRIBEHENIN (UNII: 8OC9U7TQZ0) CALCIUM BEHENATE (UNII: J5VFA9V6YG) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) ALUMINUM OXIDE (UNII: LMI26O6933) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) METHICONE (20 CST) (UNII: 6777U11MKT) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-051-03 1 in 1 CARTON 1 30 mL in 1 BOTTLE, PUMP 2 NDC:42851-051-01 15 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2012 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Owen Biosciences, Inc. 790003045 MANUFACTURE(42851-051)
