FDA.reportPublic FDA data

Reef Safe SPF 45

Manufacturer
Tropical Seas, Inc.
Effective date
2020-01-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:42:59

Label at a glance#

ProductReef Safe SPF 45
Active ingredientOCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTISALATE
Label structure10 sections

Indications and uses

helps prevent sunburn

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 children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8.0%

Octinoxate 7.5%

Oxybenzone 6.0%

Homosalate 5.0%

Octisalate 5.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, not skin cancer or early skin aging.

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

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
  • 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, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), titanium dioxide, cetyl dimethicone, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, methylparaben, cetyl alcohol (vegetable derived), 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 - Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biodegradeable

Reef Safe
BY TROPICAL SEAS ®

SPF45+

Original Formula

Water Resistant (80 minutes)

Sunscreen Lotion

4 fl. oz. (120ml)

Non-Toxic to Sealife

Principal Display Panel - Bottle Label
Principal Display Panel - Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52854-045-012022-11-29C16284748780-1d6a99b39-6ce8-a426-e053-dadaa90af4c237f7d4e9-34c9-460a-a28b-ce685e7b3b0a
52854-045-012022-01-28C16284748780-1d6a99b39-6ce8-a426-e053-dadaa90af4c237f7d4e9-34c9-460a-a28b-ce685e7b3b0a

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
homosalateACTIVE INGREDIENTV06SV4M95S1
octinoxateACTIVE INGREDIENT4Y5P7MUD511
octisalateACTIVE INGREDIENT4X49Y0596W1
octocryleneACTIVE INGREDIENT5A68WGF6WM1
oxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
homosalateACTIVE MOIETYV06SV4M95S1
octinoxateACTIVE MOIETY4Y5P7MUD511
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
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
sambucus nigra flowerINACTIVE INGREDIENT07V4DX094T1
sodium hydroxideINACTIVE INGREDIENT55X04QC32I1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
symphytum uplandicum leafINACTIVE INGREDIENTD05HXK6R3G1
taraxacum officinale leafINACTIVE INGREDIENT0022LFJ74Y1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1
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 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-04552854-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CETYL DIMETHICONE 1505L694Y0T22IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
TRICONTANYL POVIDONEN0SS3Q238DIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36IACT
METHYLPARABENA2I8C7HI9TIACT
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB

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 10 · 543 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVESICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INFILTRATIONADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJCAPSULE / ORAL3 mgExact identifier — unii candidate
10 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / RECTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SOLUTION / ORAL126 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
174 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, EXTENDED RELEASE / ORAL0.64 mgExact identifier — unii candidate
18 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACARDIACADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
diazolidinyl ureaDIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPASTE, DENTIFRICE / DENTAL0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
68 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET / ORAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ORAL400 mgExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 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
eea0812f-1f05-6735-e053-2a95a90a786537f7d4e9-34c9-460a-a28b-ce685e7b3b0a2022-11-29WarningsExact identifier
spl set id: 37f7d4e9-34c9-460a-a28b-ce685e7b3b0a

Reported adverse events (FAERS/openFDA)#

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