OTCLabels

Over the Counter Medications

OTC Medication Information: Safe Sea Sunscreen With Jellyfish Sting Protective SPF 30

SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 30 — octinoxate, octisalate, oxybenzone and titanium dioxide lotion
Nidaria Technology Ltd.

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.

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 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 — 0654350130 7 13026 10130 8

SAFE SEA Sunscreen SPF 30 With Jellyfish Sting Protective Lotion

SAFE SEA 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

Safe Sea SPF 30 A
(click image for full-size original)

Product Package Outer Label B

Safe Sea SPF 30 B
(click image for full-size original)

SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 30
octinoxate, octisalate, oxybenzone, titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65435-0131
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 5 mL in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 3 mL in 100 mL
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE 2 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Multilevel Packaging
1 NDC:65435-0131-5 118 mL in 1 BOTTLE None
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 Operations
Cellango Crystalline Ltd. 532199064 manufacture

Revised: 11/2011 Nidaria Technology Ltd.