FDA.reportPublic FDA data

Reef Safe SPF 50

Manufacturer
Tropical Seas, Inc.
Effective date
2020-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:40:34

Label at a glance#

ProductReef Safe SPF 50
Active ingredientOCTOCRYLENE, OCTISALATE, OXYBENZONE, AVOBENZONE
Label structure11 sections

Indications and 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

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 15 or higher and other sun protection measures including: limit time in the sun, esp...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 5.0%

Octisalate 5.0%

Oxybenzone 4.0%

Avobenzone 2.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aqueous extracts of: aloe barbadensis leaf extract, algae extract (hawaiian seaplant), chamomilla recutita (matricaria) flower extract, symphytum officinale (comfrey) root & leaf extract, taraxacum officinale (dandelion) leaf extract, echinacea purpurea (coneflower) extract, sambucus nigra (elder) flower extract, panax quinquefolium (ginseng) root extract, macrocystis pyrifera (kelp) extract, lavandula angustifolia (lavender) extract, cymbopogon schoenanthus (lemon grass) extract, althea officinalis (marshmallow) root extract, achillea millefolium (yarrow flower) extract, camellia sinensis (white tea) extract, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol (vegetable derived), methylparaben, diazolidinyl urea and propylparaben.

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-368-7327

Principal Display Panel - 120 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biodegradeable

Reef Safe

By Tropical Seas®

50

Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

4 fl. oz. (120ml) Sunscreen Lotion

Non-Toxic to Sealife

Principal Display Panel - 120 mL Bottle Label
Principal Display Panel - 120 mL Bottle Label

Principal Display Panel - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biodegradable

Reef Safe

By Tropical Seas®

SPF 50+

Water Resistant (80 Minutes)

Broad Spectrum SPF 50+

Sunscreen Lotion

32 fl. oz. (946 ml)

Non-Toxic to Sealife

Principal Display Panel - 946 mL Bottle LabelPrincipal Display Panel - 946 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52854-500-012022-11-29C16284748780-1d6a99b39-d4e1-a426-e053-dadaa90af4c2e767bf40-1219-4d39-8885-2a72a8bddc14
52854-500-022022-11-29C16284748780-1d6a99b39-d4e1-a426-e053-dadaa90af4c2e767bf40-1219-4d39-8885-2a72a8bddc14
52854-500-012022-01-28C16284748780-1d6a99b39-d4e1-a426-e053-dadaa90af4c2e767bf40-1219-4d39-8885-2a72a8bddc14
52854-500-022022-01-28C16284748780-1d6a99b39-d4e1-a426-e053-dadaa90af4c2e767bf40-1219-4d39-8885-2a72a8bddc14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOX1
octisalateACTIVE INGREDIENT4X49Y0596W1
octocryleneACTIVE INGREDIENT5A68WGF6WM1
oxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
avobenzoneACTIVE MOIETYG63QQF2NOX1
octisalateACTIVE MOIETY4X49Y0596W1
octocryleneACTIVE MOIETY5A68WGF6WM1
oxybenzoneACTIVE MOIETY95OOS7VE0Y1
achillea millefolium flowerINACTIVE INGREDIENTYQR8R0SQEA1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
althaea officinalis rootINACTIVE INGREDIENTTRW2FUF47H1
american ginsengINACTIVE INGREDIENT8W75VCV53Q1
carbomer copolymer type b (allyl pentaerythritol crosslinked)INACTIVE INGREDIENT809Y72KV361
carrageenanINACTIVE INGREDIENT5C69YCD2YJ1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
cetyl dimethicone 150INACTIVE INGREDIENT5L694Y0T221
chamomileINACTIVE INGREDIENTFGL3685T2X1
comfrey rootINACTIVE INGREDIENTM9VVZ08EKQ1
cymbopogon schoenanthus topINACTIVE INGREDIENT9SJI1LW39W1
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW41
echinacea, unspecifiedINACTIVE INGREDIENT4N9P6CC1DX1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
glyceryl stearate seINACTIVE INGREDIENTFCZ5MH785I1
green tea leafINACTIVE INGREDIENTW2ZU1RY8B01
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR71
lavandula angustifolia flowering topINACTIVE INGREDIENT9YT4B71U8P1
macrocystis pyriferaINACTIVE INGREDIENTK31S3OG5C41
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
phenethyl benzoateINACTIVE INGREDIENT0C143929GK1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
sambucus nigra flowerINACTIVE INGREDIENT07V4DX094T1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
symphytum uplandicum leafINACTIVE INGREDIENTD05HXK6R3G1
taraxacum officinale leafINACTIVE INGREDIENT0022LFJ74Y1
tricontanyl povidone (4 tricontanyl branches/repeat)INACTIVE INGREDIENTN0SS3Q238D1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-50052854-500-01, 52854-500-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
CETYL ALCOHOL936JST6JCNIACT
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARRAGEENAN5C69YCD2YJIACT
CHAMOMILEFGL3685T2XIACT
SYMPHYTUM UPLANDICUM LEAFD05HXK6R3GIACT
COMFREY ROOTM9VVZ08EKQIACT
TARAXACUM OFFICINALE LEAF0022LFJ74YIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
SAMBUCUS NIGRA FLOWER07V4DX094TIACT
AMERICAN GINSENG8W75VCV53QIACT
MACROCYSTIS PYRIFERAK31S3OG5C4IACT
LAVANDULA ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
PHENETHYL BENZOATE0C143929GKIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT

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 9 · 503 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
polysorbate 60POLYSORBATE 60CAL22UVI4MSUPPOSITORY / RECTAL0.05 mg/mgExact identifier — unii candidate
13 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAMUSCULAR78 mgExact identifier — unii candidate
174 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION, CONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / VAGINAL0.1 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii candidate
79 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / PERIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPOWDER / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPOWDER, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IRRIGATIONADJ PHExact identifier — unii candidate
174 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
eea0c9d3-30e9-74fc-e053-2995a90a4635e767bf40-1219-4d39-8885-2a72a8bddc142022-11-29WarningsExact identifier
spl set id: e767bf40-1219-4d39-8885-2a72a8bddc14

Reported adverse events (FAERS/openFDA)#

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