Safe Sea SPF 50

Manufacturer
SASA Cosmetics
Effective date
2015-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:41:18

Label at a glance#

ProductSafe Sea SPF 50
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  Aqua, Cyclopentasiloxane, Stearyl Dimethicone, Cetyl Dimethicone,

Propylene Glycol, Lauryl PEG / PPG - 18/18 Methicone, Cetyl PEG/PPG-10/1 Dimethicone,

Hydrogenated Castor Oil,  Panthenol, Tocopheryl Acetate, 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, Trimethoxycaprylylsilane

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octinoxate 7.5 %

Octisalate 5 %

Zinc Oxide 5 %

Titanium Dioxide 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 form excessive heat

and direct sunlight

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66134-050-502020-01-31C16284748780-19d75b9d1-0963-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66134-050-50Safe Sea SPF 50118 g in 1 TUBELOTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66134-050SAFE SEA SPF 50 (OCTINOXATE, OCTISALATE, AVOBENZONE, TITANIUM DIOXIDE) LOTION [SASA COSMETICS]2Legacy NDC, 1 package rows20150108_ac7ee36b-a361-4240-b7a3-1b36e298cf7a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M2
CETYL DIMETHICONE 25INACTIVE INGREDIENTU4AS1BW4ZB2
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0X2
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY2
LANTHANUM CHLORIDEINACTIVE INGREDIENT04M8624OXV2
LAURYL PEG/PPG-18/18 METHICONEINACTIVE INGREDIENTZJ5S27D9NX2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O2
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z2
PHAEODACTYLUM TRICORNUTUMINACTIVE INGREDIENTY5W63E7HLV2
POLYSULFATED GLYCOSAMINOGLYCANINACTIVE INGREDIENT268AW7000T2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SACCHAROMYCES CEREVISIAEINACTIVE INGREDIENT978D8U419H2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
STEARYL DIMETHICONE (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HY2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E2
TRIMETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTFZ07E4LW2M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66134-05066134-050-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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 4 · 228 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION, SOLUTION / INTRAVENOUS0.04 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAOCULAR15 mgExact identifier — unii candidate
7 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INFILTRATION0.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAVENOUS45 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, DELAYED RELEASE / ORAL3.1 mgExact identifier — unii candidate
12 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, EXTENDED RELEASE / ORAL410.82 mgExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAVENOUS0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSUSPENSION / ORAL40 mgExact identifier — unii candidate
19 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / VAGINAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSOLUTION / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SOLUTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMSYRUP / ORAL20 mgExact identifier — unii candidate
23 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION / INTRAPERITONEAL0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUINJECTION / INTRAMUSCULAR0.01 %w/vExact identifier — unii candidate
12 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / INTRALESIONAL23 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / SUBCUTANEOUS225 mgExact identifier — unii candidate
50 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, FILM COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
23 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
50 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRA-ARTICULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46af1cb0-86e5-4a67-b80d-fb1b0c39440cac7ee36b-a361-4240-b7a3-1b36e298cf7a2015-01-07WarningsExact identifier
spl id: 46af1cb0-86e5-4a67-b80d-fb1b0c39440c
spl set id: ac7ee36b-a361-4240-b7a3-1b36e298cf7a

Reported adverse events (FAERS/openFDA)#

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