Label: SAFE SEA SPF 30- zinc oxide lotion
- NDC Code(s): 65435-0600-1
- 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
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
- Sun Protection MeasuresSpending time in the sun increases your risk of 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 10 a.m.to 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor.
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Other Information
- Give particular 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 not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings.
- In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file.
- Protect this product from excessive heat and direct sun.
- KEEP OUT OF REACH OF CHILDREN
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Inactive ingredients
Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
- Product label
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INGREDIENTS AND APPEARANCE
SAFE SEA SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10.9 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIBUTYL ADIPATE (UNII: F4K100DXP3) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) MAGNESIUM STEARATE (UNII: 70097M6I30) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65435-0600-1 100 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/01/2025 Labeler - Nidaria Technology Ltd. (514977487) Establishment Name Address ID/FEI Business Operations Anna Lotan Ltd. 600458368 manufacture(65435-0600)
