Safe Sea For Kids Sunscreen With Jellyfish Sting Protective SPF 30 Plus

Dosage form: lotion
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 5mL in 100mL, OXYBENZONE 3mL in 100mL, TITANIUM DIOXIDE 2mL in 100mL
Labeler: Nidaria Technology Ltd.
NDC Code: 65435-0133

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.

Safe Sea For Kids Sunscreen With Jellyfish Sting Protective SPF 30 Plus

Active Ingredients

Active Ingredients                                                                                          Purpose
Octinoxate 7.5 %, Octisalate 5 %, Oxybenzone 3 %, Titanium Dioxide 2 %....Sunscreen

Uses

- Helps prevent sunburn.  - Sun Protection Factor 30.  - 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, Mineral Oil, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Diazolidinyl Urea, Propylparaben, Methylparaben, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride.

Purpose

Sunscreen

Description

SAFE SEA Kids Sunscreen SPF 30+ 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 - 0654350131  7 13026 10132 2

SAFE SEA Kids Sunscreen SPF 30+ With Jellyfish Sting Protective Lotion

SAFE SEA FOR KIDS Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 30+ 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

SAFE SEA FOR KIDS SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 30 PLUS 
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65435-0133
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 mL  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE3 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
MINERAL OIL 
SODIUM DICHLOROACETATE 
HYDROGENATED CASTOR OIL 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
PROPYLPARABEN 
METHYLPARABEN 
MAGNESIUM CHLORIDE 
SODIUM CITRATE 
EDETATE SODIUM 
TRIMETHOXYCAPRYLYLSILANE 
CALCIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:65435-0133-5118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/12/2011
Labeler - Nidaria Technology Ltd. (514977487)
Establishment
NameAddressID/FEIOperations
Cellango Crystalline Ltd.532199064manufacture

Revised: 11/2011
 
Nidaria Technology Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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