Label: SAFE SEA SPF 50 MINERAL- zinc oxide lotion
- NDC Code(s): 65435-0400-1
- Packager: Nidaria Technology Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 24, 2025
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Other information
- Give perticular attention to coverage of arms and legs.
- In water infested by sea Lice, safe sea should also be applied under the bathing suit.
- Jellyfish can be dangerous. This product should be considered a recommendation to go into jellyfish infested water, nor is it guarantee against stings.
- In case of stings do not use Safe sea as a treatement - seek medical attention. *Tested against sea nettle (Chrysaora), Atlantic box jellyfish (Chiropsalmus) & Rhopilema.Data on file.
- Protect this product from excessive heat and direact sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- reapply: after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
- Sun protection Measure- Spending time in the sun increase your skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months : Ask a doctor
- Uses
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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.
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- Product label
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INGREDIENTS AND APPEARANCE
SAFE SEA SPF 50 MINERAL
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 210 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:65435-0400-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 06/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/20/2023 Labeler - Nidaria Technology Ltd. (514977487) Establishment Name Address ID/FEI Business Operations Cosmetics & Cleaners International, LLC. DBA C&C Industries 018949897 manufacture(65435-0400)
