NDC 58443-0308

Pelagic Broad Spectrum SPF 50 Sunscreen

Titanium Dioxide, Zinc Oxide

Pelagic Broad Spectrum SPF 50 Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Prime Enterprises Inc.. The primary component is Titanium Dioxide; Zinc Oxide.

• Product ID: 58443-0308_9d367c17-19db-4f31-e053-2995a90ad246
• NDC: 58443-0308
• Product Type: Human Otc Drug
• Proprietary Name: Pelagic Broad Spectrum SPF 50 Sunscreen
• Generic Name: Titanium Dioxide, Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-10-24
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Prime Enterprises Inc.
• Substance Name: TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 45 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58443-0308-3

88.7 mL in 1 BOTTLE (58443-0308-3)

• Marketing Start Date: 2019-10-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58443-0308-3 [58443030803]

Pelagic Broad Spectrum SPF 50 Sunscreen LOTION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-10-24

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	44.6 mg/mL

NDC Crossover Matching brand name "Pelagic Broad Spectrum SPF 50 Sunscreen" or generic name "Titanium Dioxide, Zinc Oxide"

NDC	Brand Name	Generic Name
58443-0309	Pelagic Broad Spectrum SPF 50 Sunscreen	Pelagic Broad Spectrum SPF 50 Sunscreen
58443-0308	Pelagic Broad Spectrum SPF 50 Sunscreen	Pelagic Broad Spectrum SPF 50 Sunscreen
10477-1003	All Physical Sunscreen Broad Spectrum SPF 50	Titanium Dioxide, Zinc Oxide
0311-0710	ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20	Titanium Dioxide, Zinc Oxide
10096-0241	Anew Solar Advance	TITANIUM DIOXIDE, ZINC OXIDE
10096-0260	Avon	Titanium Dioxide, Zinc Oxide
0316-2056	Blue Lizard Sensitive Face Sunscreen	Titanium Dioxide, Zinc Oxide
0316-2064	Blue Lizard Sheer SPF 50 Sunscreen	Titanium Dioxide, Zinc Oxide
0187-2204	CeraVe	Titanium Dioxide, Zinc Oxide
0187-2205	CeraVe	Titanium Dioxide, Zinc Oxide
0187-2208	CeraVe	Titanium Dioxide, Zinc Oxide
0187-2209	CeraVe	Titanium Dioxide, Zinc Oxide
0187-2210	CeraVe	Titanium Dioxide, Zinc Oxide
0299-5889	Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 20	titanium dioxide, zinc oxide
0299-4111	Cetaphil Sheer Mineral Sunscreen SPF 30	titanium dioxide, zinc oxide
0299-4112	Cetaphil Sheer Mineral Sunscreen SPF 50	titanium dioxide, zinc oxide
0299-4122	Cetaphil Sheer Mineral Sunscreen SPF 50	titanium dioxide, zinc oxide
0299-4108	Cetaphil Sheer Mineral Sunscreen Stick SPF 50	titanium dioxide, zinc oxide
11090-114	ITC Bye Bye Foundation Full Coverage Moisturizer Fair	Titanium Dioxide, Zinc Oxide
11090-115	ITC Bye Bye Foundation Full Coverage Moisturizer Fair Light	Titanium Dioxide, Zinc Oxide
11090-103	ITC CC Full Coverage Cream Fair	Titanium Dioxide, Zinc Oxide
11090-104	ITC CC Full Coverage Cream Fair Light	Titanium Dioxide, Zinc Oxide
11090-105	ITC CC Full Coverage Cream Light	Titanium Dioxide, Zinc Oxide
11090-106	ITC CC Full Coverage Cream Light Medium	Titanium Dioxide, Zinc Oxide
11090-107	ITC CC Full Coverage Cream Medium	Titanium Dioxide, Zinc Oxide
11090-109	ITC CC Full Coverage Cream Medium Tan	Titanium Dioxide, Zinc Oxide
11090-108	ITC CC Full Coverage Cream Neutral Medium	Titanium Dioxide, Zinc Oxide
11090-110	ITC CC Full Coverage Cream Neutral Tan	Titanium Dioxide, Zinc Oxide
11090-112	ITC CC Full Coverage Cream Rich	Titanium Dioxide, Zinc Oxide
11090-113	ITC CC Full Coverage Cream Rich Honey	Titanium Dioxide, Zinc Oxide
11090-111	ITC CC Full Coverage Cream Tan	Titanium Dioxide, Zinc Oxide
0363-3560	OLOGY	TITANIUM DIOXIDE, ZINC OXIDE
10967-670	PREVAGE CITY SMART	TITANIUM DIOXIDE, ZINC OXIDE
10967-631	REVLON PHOTOREADY INSTA-FIX MAKEUP	titanium dioxide, zinc oxide
0363-0962	WALGREENS KIDS BABY SPF 50	Titanium Dioxide, Zinc oxide