SAFE SEA SPF 50 MINERAL- zinc oxide lotion

Safe Sea SPF 50 Mineral by

Drug Labeling and Warnings

Safe Sea SPF 50 Mineral by is a Otc medication manufactured, distributed, or labeled by Nidaria Technology Ltd., Cosmetics & Cleaners International, LLC. DBA C&C Industries. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc oxide 21%

Purpose

Sunscreen

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

• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

• Helps prevent sunburn
• If used as direacted with other sun protection measures (see directions), decreases the risk of skin cancer and early aging skin caused by the sun

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

INGREDIENTS AND APPEARANCE

SAFE SEA SPF 50 MINERAL 
zinc oxide lotion

Product 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)