Label: SAFE SEA SPF 50 MINERAL- zinc oxide lotion
- NDC Code(s): 65435-0400-1
- Packager: Nidaria Technology Ltd.
- Category: HUMAN OTC DRUG LABEL
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 8, 2023
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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.
- 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 final part352 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)
