SAFE SEA SPF 30- zinc oxide lotion

Safe Sea SPF 30 by

Drug Labeling and Warnings

Safe Sea SPF 30 by is a Otc medication manufactured, distributed, or labeled by Nidaria Technology Ltd., Anna Lotan Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 10.9%

Purpose

Sunscreen

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

Warnings

• For external use only 
• Do not use on damagedor broken skin
• When using this productkeep out of eyes. Rinse with water to remove
• Stop use and ask a doctorif 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 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.

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

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

INGREDIENTS AND APPEARANCE

SAFE SEA SPF 30 
zinc oxide lotion

Product 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
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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)