FDA.reportPublic FDA data

Reef Safe SPF 15

Manufacturer
Tropical Seas, Inc.
Effective date
2020-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:41:11

Label at a glance#

ProductReef Safe SPF 15
Active ingredientHOMOSALATE, OCTINOXATE, OXYBENZONE, 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

Homosalate 10.0%

Octinoxate 4.0%

Oxybenzone 4.0%

Octisalate 2.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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

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
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ethanol, 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, acrylates octylacrylamide co-polymer, c12-15 alcohols benzoate, cyclopentasiloxane, octyldodecyl neopentanoate, and fragrance.

Other Information

SPL UNCLASSIFIED SECTION

  • WARNING: Flammable
    • do not use near open flame or heat source
  • hold approximately 10 - 12 inches from skin to spray
  • spray into palm of hand, rub together, then apply to your face
  • do not spray directly into your face so that it won't get in your eyes.
  • rub into skin evenly to ensure appropriate coverage
  • 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

15

Original Formula SPF 15+

Water Resistant (80 minutes)

8.45 fl. oz. (250ml) Sprayable Sunscreen

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
52854-016-012022-11-29C16284748780-1d6a99b39-a0ce-a426-e053-dadaa90af4c2d4dd1b7d-cff6-4bba-95cf-9f8ac836935d
52854-016-012022-01-28C16284748780-1d6a99b39-a0ce-a426-e053-dadaa90af4c2d4dd1b7d-cff6-4bba-95cf-9f8ac836935d

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
homosalateACTIVE INGREDIENTV06SV4M95S1
octinoxateACTIVE INGREDIENT4Y5P7MUD511
octisalateACTIVE INGREDIENT4X49Y0596W1
oxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
homosalateACTIVE MOIETYV06SV4M95S1
octinoxateACTIVE MOIETY4Y5P7MUD511
octisalateACTIVE MOIETY4X49Y0596W1
oxybenzoneACTIVE MOIETY95OOS7VE0Y1
achillea millefolium flowerINACTIVE INGREDIENTYQR8R0SQEA1
alcoholINACTIVE INGREDIENT3K9958V90M1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQ1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
althaea officinalis rootINACTIVE INGREDIENTTRW2FUF47H1
american ginsengINACTIVE INGREDIENT8W75VCV53Q1
carrageenanINACTIVE INGREDIENT5C69YCD2YJ1
chamomileINACTIVE INGREDIENTFGL3685T2X1
comfrey rootINACTIVE INGREDIENTM9VVZ08EKQ1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
cymbopogon schoenanthus topINACTIVE INGREDIENT9SJI1LW39W1
echinacea, unspecifiedINACTIVE INGREDIENT4N9P6CC1DX1
green tea leafINACTIVE INGREDIENTW2ZU1RY8B01
lavandula angustifolia flowering topINACTIVE INGREDIENT9YT4B71U8P1
macrocystis pyriferaINACTIVE INGREDIENTK31S3OG5C41
octyldodecyl neopentanoateINACTIVE INGREDIENTX8725R883T1
sambucus nigra flowerINACTIVE INGREDIENT07V4DX094T1
symphytum uplandicum leafINACTIVE INGREDIENTD05HXK6R3G1
taraxacum officinale leafINACTIVE INGREDIENT0022LFJ74Y1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-01652854-016-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
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
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 50THT5PCI0RIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
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 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPOWDER / RESPIRATORY (INHALATION)1 mgExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJGRANULE, FOR SUSPENSION / ORAL161 mgExact identifier — unii candidate
10 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJCAPSULE, DELAYED RELEASE / ORAL1 mgExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPOWDER / NASALNAExact identifier — unii candidate
10 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJPOWDER, FOR SUSPENSION / ORAL15 mgExact identifier — unii candidate
10 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 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
eea06170-076f-c6ea-e053-2a95a90af653d4dd1b7d-cff6-4bba-95cf-9f8ac836935d2022-11-29WarningsExact identifier
spl set id: d4dd1b7d-cff6-4bba-95cf-9f8ac836935d

Reported adverse events (FAERS/openFDA)#

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