SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 50- octinoxate, octisalate, zinc oxide, titanium dioxide lotion

Safe Sea Sunscreen With Jellyfish Sting Protective SPF 50 by

Drug Labeling and Warnings

Safe Sea Sunscreen With Jellyfish Sting Protective SPF 50 by is a Otc medication manufactured, distributed, or labeled by Nidaria Technology Ltd., Cellango Crystalline Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients                                                                                         Purpose
Octinoxate 7.5 %, Octisalate 5 %, Zinc Oxide 5 %, Titanium Dioxide 2 %.....Sunscreen

Uses

- Helps prevent sunburn.  - Sun Protection Factor 50.  - Retains SPF after 80 minutes of activity in the water or perspiring.

Warning

- For external use only.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if skin irritation or rash develops.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

- Adults and children six months of age and older. Apply Liberally to all exposed areas 10 minutes before sun or water exposure.  - Ensure complete coverage.  - Reapply after prolonged swimmimg and towel drying.

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) and Rhopilema. Date on file.

Inactive ingredients

Deionized Water, Cyclomethicone, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Propylparaben, Methylparaben, Chlorphenesin, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride.

Purpose

Sunscreen

Description

SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion  The world's only sunscreen lotion scientifically developed to help prevent the stings from most jellyfish*, Sea nettle, Sea lice (Seabathers eruption).  Dermatologist tested. UVAandUVB protection For sensitive skin. Water resistant.  Distributed by  Nidaria Technology ltd.  420 Lexington Avenue Suite 2400 New York, New York 10170  Made in Israel. www.nidaria.com  US Patents No. 6338837 / 6406709 / 6132747  NDC - 0654350150  7 13026 10150 6

PRINCIPAL DISPLAY PANEL

SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion

PRINCIPAL DISPLAY PANEL

SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 50 Helps Prevent Stings from Jellyfish and Sea Lice  UVA, UVB, Water Resistant Clinically Tested  4 fl. oz. (118 ml)

Product Package Outer Label A

Product Package Outer Label B

INGREDIENTS AND APPEARANCE

SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 50 
octinoxate, octisalate, zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65435-0151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS)	ZINC OXIDE	5 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
SODIUM DICHLOROACETATE (UNII: 42932X67B5)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
CHLORPHENESIN (UNII: I670DAL4SZ)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE SODIUM (UNII: MP1J8420LU)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65435-0151-5	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/12/2011

Labeler - Nidaria Technology Ltd. (514977487)

Establishment
Name	Address	ID/FEI	Business Operations
Cellango Crystalline Ltd.		532199064	manufacture