SAFE SEA SPF 50 MINERAL- zinc oxide lotion 
Nidaria Technology Ltd.

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.

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Drug Facts

Active ingredient

Zinc oxide 21%

Purpose

Sunscreen

Other information

Warnings

Directions

Uses

Inactive ingredients

Benzoic acid, Benzyl alcohol, Bis-Octyldodecyl, Dimer Dilinoleate/ Propanediol copolymer, Butyloctyl Salicylate, C12 -15 Alkyl benzoate, Calcium chloride, Caprylic / Capric triglyceride, Chlorphenesin, Dehydroacetic acid, Dibutyl Adipate, Hydrogenated Caster oil, Isopropyl Myristate, Lanthanum chloride, Magnesium Chloride, Magnesium stearate, Panthenol, Polyglycerly-2Dipolyhydroxystearate, Sorbic acid, Tocopheryl Acetate, Triethoxycaprylylsilane, water.

Product label

image description

SAFE SEA SPF 50 MINERAL 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65435-0400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION210 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LANTHANUM CHLORIDE (UNII: 04M8624OXV)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65435-0400-160 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/20/2023
Labeler - Nidaria Technology Ltd. (514977487)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetics & Cleaners International, LLC. DBA C&C Industries018949897manufacture(65435-0400)

Revised: 6/2023
Document Id: fda1e66f-8a41-8034-e053-6394a90a783e
Set id: f6cf9454-552b-486e-a38b-ab3c183b24a1
Version: 1
Effective Time: 20230608
 
Nidaria Technology Ltd.