NDC 53675-180

Broad Spectrum SPF 30 Water Resistant (80 Minutes)

Titanium Dioxide, Zinc Oxide

Broad Spectrum SPF 30 Water Resistant (80 Minutes) is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Aruba Aloe Balm Nv. The primary component is Titanium Dioxide; Zinc Oxide.

• Product ID: 53675-180_70cb5532-bf4f-d9bf-e053-2a91aa0acb1f
• NDC: 53675-180
• Product Type: Human Otc Drug
• Proprietary Name: Broad Spectrum SPF 30 Water Resistant (80 Minutes)
• Generic Name: Titanium Dioxide, Zinc Oxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-09-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Aruba Aloe Balm NV
• Substance Name: TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 100 mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53675-180-00

177 mL in 1 TUBE (53675-180-00)

• Marketing Start Date: 2018-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53675-180-00 [53675018000]

Broad Spectrum SPF 30 Water Resistant (80 Minutes) CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-09-01

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	100 mg/mL

OpenFDA Data

• SPL SET ID: 20830b77-b37b-4cea-8786-bd379bbfeeb3
• Manufacturer:
  • Aruba Aloe Balm NV
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
• UPC Code:
  • 0082252071403

NDC Crossover Matching brand name "Broad Spectrum SPF 30 Water Resistant (80 Minutes)" or generic name "Titanium Dioxide, Zinc Oxide"

NDC	Brand Name	Generic Name
53675-180	Broad Spectrum SPF 30 Water Resistant (80 Minutes)	Broad Spectrum SPF 30 Water Resistant (80 Minutes)
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