Safe Sea

Manufacturer: SASA Cosmetics
Effective date: 2015-01-06
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 22:41:18

Label at a glance#

ProductSafe Sea

Active ingredientOCTINOXATE, ZINC OXIDE

Label structure9 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aqua, Cyclopentasiloxane, Mineral Oil, Lauryl

PEG/PEG - 18/18 Methicone, Cetyl

Dimethicone, Stearyl Dimethicone, Ceresin,

Hydrogenated Castor Oil, Propylene Glycol,

Lanthanum Chloride, Magnesium Chloride,

Calcium Chloride, Plankton Extract, Glycoproteins, Glycosaminoglycans,

Benzyl Alcohol, Fragrance, Chlorphenesin, Benzoic Acid, Sorbic Acid,

Dehydroacetic Acid, Tetrasodium EDTA, Sodium Citrate, Triethoxycaprylylsilane

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octinoxate 7.5 %

Zinc Oxide 2 %

OTC - PURPOSE SECTION

Purpose:

Sunscreen

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn -- If used as directed with other sun

protection measures ( see directions), decreases the risk of skin cancer

and early skin aging caused by the sun

WARNINGS SECTION

Warning: -For external use only -- Do not use on damaged or broken skin

--When using this product keep out of eyes. Rinse with water to

remove -- Stop sue and ask a doctor if rash occurs--Keep out of reach

of children -- If product is swallowed, get medical help or contact a Poison

Control Center right away.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply liberally 15 minutes before sun exposure --

reapply. After 80 minutes of swimming or sweating, immediately after towel

drying and at least every 2 hours -- Sun Protection Measures-Spending time in the

sun increases your risk of skin cancer and early skin aging. To

decrease this risk, regularly use a sunscreen with a broad spectrum SPF of

15 or higher and other sun protection measures including: - Limit time

in the sun, especially from 10 a.m. to 2 p.m. -- Wear long-sleeve shirts, pants,

hats, and sunglasses -- Children under 6 months: Ask a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or

contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

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. Data on file. - Protect this product from excessive heat and direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of label

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
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
66134-015-15	2020-01-31	C162847	48780-1	9d75b9d0-dd83-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66134-015-15	Safe Sea	118 g in 1 TUBE	LOTION	118		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66134-015	SAFE SEA (OCTINOXATE, ZINC OXIDE) LOTION [SASA COSMETICS]	3	Legacy NDC, 1 package rows	20150108_fbf07c1d-de8a-411e-9a39-c7611ab5af4b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	3
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	3
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	3
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	3
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	3
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	3
CETYL DIMETHICONE 25	INACTIVE INGREDIENT	U4AS1BW4ZB	3
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	3
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	3
DEHYDROACETIC ACID	INACTIVE INGREDIENT	2KAG279R6R	3
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	3
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	3
LANTHANUM CHLORIDE	INACTIVE INGREDIENT	04M8624OXV	3
LAURYL PEG/PPG-18/18 METHICONE	INACTIVE INGREDIENT	ZJ5S27D9NX	3
MAGNESIUM CHLORIDE	INACTIVE INGREDIENT	02F3473H9O	3
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	3
PHAEODACTYLUM TRICORNUTUM	INACTIVE INGREDIENT	Y5W63E7HLV	3
POLYSULFATED GLYCOSAMINOGLYCAN	INACTIVE INGREDIENT	268AW7000T	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SACCHAROMYCES CEREVISIAE	INACTIVE INGREDIENT	978D8U419H	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
STEARYL DIMETHICONE (400 MPA.S AT 50C)	INACTIVE INGREDIENT	R327X197HY	3
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Safe Sea
OCTINOXATE, ZINC OXIDE
OCTINOXATE
ZINC OXIDE
WATER
CYCLOMETHICONE 5
MINERAL OIL
LAURYL PEG/PPG-18/18 METHICONE
CETYL DIMETHICONE 25
STEARYL DIMETHICONE (400 MPA.S AT 50C)
CERESIN
HYDROGENATED CASTOR OIL
PROPYLENE GLYCOL
LANTHANUM CHLORIDE
MAGNESIUM CHLORIDE
CALCIUM CHLORIDE
POLYSULFATED GLYCOSAMINOGLYCAN
BENZYL ALCOHOL
CHLORPHENESIN
BENZOIC ACID
SORBIC ACID
DEHYDROACETIC ACID
EDETATE SODIUM
SODIUM CITRATE
TRIETHOXYCAPRYLYLSILANE
PHAEODACTYLUM TRICORNUTUM
SACCHAROMYCES CEREVISIAE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66134-015	66134-015-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
WATER	059QF0KO0R	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
MINERAL OIL	T5L8T28FGP	IACT
LAURYL PEG/PPG-18/18 METHICONE	ZJ5S27D9NX	IACT
CETYL DIMETHICONE 25	U4AS1BW4ZB	IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)	R327X197HY	IACT
CERESIN	Q1LS2UJO3A	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
LANTHANUM CHLORIDE	04M8624OXV	IACT
MAGNESIUM CHLORIDE	02F3473H9O	IACT
CALCIUM CHLORIDE	M4I0D6VV5M	IACT
POLYSULFATED GLYCOSAMINOGLYCAN	268AW7000T	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
CHLORPHENESIN	I670DAL4SZ	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
SORBIC ACID	X045WJ989B	IACT
DEHYDROACETIC ACID	2KAG279R6R	IACT
EDETATE SODIUM	MP1J8420LU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
PHAEODACTYLUM TRICORNUTUM	Y5W63E7HLV	IACT
SACCHAROMYCES CEREVISIAE	978D8U419H	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 5 · 257 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	CAPSULE / ORAL		2 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET / ORAL		232 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
MAGNESIUM CHLORIDE	MAGNESIUM CHLORIDE	02F3473H9O	INJECTION, SOLUTION / INTRATHECAL		1 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	OINTMENT / TOPICAL		1097 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	GEL / RECTAL		11 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
CERESIN	CERESIN	Q1LS2UJO3A	CREAM / VAGINAL		280 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, EXTENDED RELEASE / ORAL		393 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / ENDOTRACHEAL		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
CALCIUM CHLORIDE	CALCIUM CHLORIDE	M4I0D6VV5M	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 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	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SOLUTION / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	LOTION / TOPICAL		4 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SOLUTION / OPHTHALMIC	0.2 %w/v		Exact identifier — unii candidate 19 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
6dc377d1-8a9d-4d4e-b958-e8485efd9181			fbf07c1d-de8a-411e-9a39-c7611ab5af4b	2015-01-06	Warnings	Exact identifier spl id: 6dc377d1-8a9d-4d4e-b958-e8485efd9181 spl set id: fbf07c1d-de8a-411e-9a39-c7611ab5af4b

Reported adverse events (FAERS/openFDA)#

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