Safe Sea Sunscreen With Jellyfish Sting Protective Spf 50

Safe Sea Sunscreen With Jellyfish Sting Protective Spf 50
SPL v2
SPL
SPL Set ID 08fa0c77-3134-4f71-bd5d-b5286d1793bb
Route
TOPICAL
Published
Effective Date 2011-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mL) Octisalate (5 mL) Zinc (2 mL) Titanium
Inactive Ingredients
Water Cyclomethicone Sodium Dichloroacetate Hydrogenated Castor Oil Propylene Glycol Propylparaben Methylparaben Chlorphenesin Magnesium Chloride Sodium Citrate Edetate Sodium Triethoxycaprylylsilane Trimethoxycaprylylsilane Calcium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-11-12

Description

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

Purpose

Sunscreen


Medication Information

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

Uses

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

Section 51945-4

SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion

Warning

- For external use only.

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.

Active Ingredients

Active Ingredients                                                                                         Purpose

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

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.

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.

Product Package Outer Label A

Product Package Outer Label B


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

SAFE SEA Sunscreen SPF 50 With Jellyfish Sting Protective Lotion

Purpose

Sunscreen

Warning

- For external use only.

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.

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

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.

Active Ingredients

Active Ingredients                                                                                         Purpose

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

Inactive Ingredients (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.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if skin irritation or rash develops.

Keep Out of Reach of Children (Keep out of reach of children)

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

Product Package Outer Label A

Product Package Outer Label B


Advanced Ingredient Data


Raw Label Data

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