NDC 58443-0195

Abella ColorShade SPF 35 Medium

Octinoxate And Zinc Oxide

Abella ColorShade SPF 35 Medium is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Zinc Oxide; Octinoxate.

• Product ID: 58443-0195_7d8d3ebb-5541-51b9-e053-2a91aa0a4aba
• NDC: 58443-0195
• Product Type: Human Otc Drug
• Proprietary Name: Abella ColorShade SPF 35 Medium
• Generic Name: Octinoxate And Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2013-08-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: ZINC OXIDE; OCTINOXATE
• Active Ingredient Strength: 29 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58443-0195-3

60 mL in 1 BOTTLE (58443-0195-3)

• Marketing Start Date: 2013-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0195-3 [58443019503]

Abella ColorShade SPF 35 Medium LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-01

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	29.4 mg/mL

OpenFDA Data

• SPL SET ID: 2185064e-163b-5a59-e054-00144ff8d46c
• Manufacturer:
  • Prime Enterprises Inc.
• UNII:
  • SOI2LOH54Z
  • 4Y5P7MUD51

NDC Crossover Matching brand name "Abella ColorShade SPF 35 Medium" or generic name "Octinoxate And Zinc Oxide"

NDC	Brand Name	Generic Name
58443-0195	Abella ColorShade SPF 35 Medium	Abella ColorShade SPF 35 Medium
0187-2490	CeraVe	octinoxate and zinc oxide
13537-489	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-571	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-572	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-573	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-574	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-575	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-576	CYZONE STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20	Octinoxate and Zinc Oxide
13537-958	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-959	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-960	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-966	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-967	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-968	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-969	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-970	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-971	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-972	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-973	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-974	ESIKA PRO HIDRACOLOR 3 IN 1 Moisturizing, color and perfecting effect SPF 25	OCTINOXATE and ZINC OXIDE
13537-853	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-854	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-855	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-856	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-857	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-858	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-859	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-860	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-861	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-862	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-863	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-864	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-865	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-866	ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25	Octinoxate and Zinc Oxide
13537-508	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
13537-509	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
13537-510	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
13537-569	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
13537-755	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
13537-756	LBEL ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20	Octinoxate and Zinc Oxide
11410-603	Proactiv	OCTINOXATE and ZINC OXIDE
11410-017	Proactiv Solution Oil Free Moisture SPF 15 Moisturizer	OCTINOXATE and ZINC OXIDE
10348-003	SHEER FOCUS	OCTINOXATE and ZINC OXIDE