Label: OCEAN SAFE SUNSCREEN- titanium dioxide cream
- NDC Code(s): 80325-003-01
- Packager: Naturally Uncommon, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 23, 2022
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- DRUG FACTS Active Ingredients
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INACTIVE INGREDIENTS
Deionized Water, Aqueous Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid and Sorbic Acid.
*Organic Ingredients.MANUFACTURED FOR
NATURALLY UNCOMMON, LLC
ATKINSON, NH03811
fishermanhandscrub.com - PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OCEAN SAFE SUNSCREEN
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80325-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 88 mg in 88 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HOLY BASIL LEAF (UNII: SCJ765569P) ALARIA ESCULENTA (UNII: EJ9JK8J58D) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) ALOE (UNII: V5VD430YW9) TRICAPRIN (UNII: O1PB8EU98M) COCO-GLYCERIDES (UNII: ISE9I7DNUG) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) SORBITAN OLIVATE (UNII: MDL271E3GR) CETEARYL OLIVATE (UNII: 58B69Q84JO) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) COCONUT OIL (UNII: Q9L0O73W7L) STEARIC ACID (UNII: 4ELV7Z65AP) LUVISET 360 (UNII: 05BG6GY6YK) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) BENZYL ALCOHOL (UNII: LKG8494WBH) SALICYLIC ACID (UNII: O414PZ4LPZ) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80325-003-01 88 mL in 1 TUBE; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 07/01/2022 Labeler - Naturally Uncommon, LLC (044473410) Establishment Name Address ID/FEI Business Operations Stream2Sea, LLC 052920828 manufacture(80325-003)
