Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15

Manufacturer: Nidaria Technology Ltd. | Cellango Crystalline Ltd.
Effective date: 2011-11-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:30:19

Label at a glance#

ProductSafe Sea Sunscreen With Jellyfish Sting Protective SPF 15

Active ingredientOCTINOXATE, ZINC OXIDE

Label structure15 sections

Indications and uses

- Helps prevent sunburn. - Sun Protection Factor 15. - Retains SPF after 80 minutes of activity in the water or perspiring.

Dosage and administration

- 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.

Contacts and useful links#

Websitewww.nidaria.com

www.nidaria.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose
Octinoxate 7.5 %, Zinc Oxide 2 %.............................Sunscreen

Uses

INDICATIONS & USAGE SECTION

- Helps prevent sunburn. - Sun Protection Factor 15. - Retains SPF after 80 minutes of activity in the water or perspiring.

Warning

WARNINGS SECTION

- For external use only.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if skin irritation or rash develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Other Information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Deionized Water, Cyclomethicone, Mineral Oil, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, 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

OTC - PURPOSE SECTION

Sunscreen

Description

DESCRIPTION SECTION

SAFE SEA Sunscreen SPF 15 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 - 0654350115 7 13026 10115 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 15 Helps Prevent Stings from Jellyfish and Sea Lice UVA, UVB, Water Resistant Clinically Tested 4 fl. oz. (118 ml)

Product Package Outer Label A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safe Sea SPF 15 A

Product Package Outer Label B

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safe Sea SPF 15 B

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65435-0116-5	2019-11-13	C162847	48780-1	97449f38-bb97-f6ea-e053-dbdaa90aa703	Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65435-0116-5	Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15	118 mL in 1 BOTTLE	LOTION	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65435-0116	SAFE SEA SUNSCREEN WITH JELLYFISH STING PROTECTIVE SPF 15 (OCTINOXATE, ZINC OXIDE) LOTION [NIDARIA TECHNOLOGY LTD.]	2	Legacy NDC, 1 package rows	20111215_045ded38-5d0a-45b3-951f-a58ae3cf5516.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
ZINC	ACTIVE MOIETY	J41CSQ7QDS	2
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	2
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	2
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	2
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	2
SODIUM DICHLOROACETATE	INACTIVE INGREDIENT	42932X67B5	2
TRIMETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	FZ07E4LW2M	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15
OCTINOXATE, ZINC OXIDE
OCTINOXATE
ZINC OXIDE
ZINC
WATER
CYCLOMETHICONE
MINERAL OIL
SODIUM DICHLOROACETATE
HYDROGENATED CASTOR OIL
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
PROPYLPARABEN
METHYLPARABEN
MAGNESIUM CHLORIDE
SODIUM CITRATE
EDETATE SODIUM
TRIMETHOXYCAPRYLYLSILANE
CALCIUM CHLORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65435-0116	65435-0116-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
WATER	059QF0KO0R	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
MINERAL OIL	T5L8T28FGP	IACT
SODIUM DICHLOROACETATE	42932X67B5	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MAGNESIUM CHLORIDE	02F3473H9O	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
EDETATE SODIUM	MP1J8420LU	IACT
TRIMETHOXYCAPRYLYLSILANE	FZ07E4LW2M	IACT
CALCIUM CHLORIDE	M4I0D6VV5M	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 313 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	CAPSULE, EXTENDED RELEASE / ORAL	410.82 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	INJECTION / INTRAMUSCULAR	4 %w/v		Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	CAPSULE / RESPIRATORY (INHALATION)		3 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	CREAM, AUGMENTED / TOPICAL	7.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	CONCENTRATE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 16 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fdb6b8cf-f655-47b6-8052-623a40d2ff2a			045ded38-5d0a-45b3-951f-a58ae3cf5516	2011-11-12	Warnings	Exact identifier spl id: fdb6b8cf-f655-47b6-8052-623a40d2ff2a spl set id: 045ded38-5d0a-45b3-951f-a58ae3cf5516

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.