FDA.reportPublic FDA data

Reef Safe SPF 50 Oxybenzone Free

Manufacturer
Tropical Seas, Inc.
Effective date
2020-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:40:57

Label at a glance#

ProductReef Safe SPF 50 Oxybenzone Free
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure10 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 10.0%

Octisalate 5.0%

Avobenzone 3.0%

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

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

Biodegradable

Reef Safe®
BY TROPICAL SEAS

Oxybenzone Free

50

Broad Spectrum SPF 50

Water Resistant (80 minutes)

8.45 fl. oz. (250ml) Sprayable Sunscreen

Non-Toxic to Sealife

Principal Display Panel - Bottle LabelPrincipal Display Panel - Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52854-518-012022-11-29C16284748780-1d6a99b39-a12e-a426-e053-dadaa90af4c25c70ddd2-ddd2-4966-8700-c528a07eee19
52854-518-012022-01-28C16284748780-1d6a99b39-a12e-a426-e053-dadaa90af4c25c70ddd2-ddd2-4966-8700-c528a07eee19

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52854-51852854-518-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

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
eea09985-a17e-6468-e053-2a95a90a661b5c70ddd2-ddd2-4966-8700-c528a07eee192022-11-29WarningsExact identifier
spl set id: 5c70ddd2-ddd2-4966-8700-c528a07eee19

Reported adverse events (FAERS/openFDA)#

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