Reef Babies SPF 50

Manufacturer
Tropical Seas, Inc.
Effective date
2014-10-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:34:50

Label at a glance#

ProductReef Babies SPF 50
Active ingredientoctocrylene, octisalate, oxybenzone, 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 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 Babies

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

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
52854-55052854-550-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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 9 · 503 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
glycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSPRAY / NASAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / ORAL100 mgExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / INTRAMUSCULAR0.13 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
carbomer copolymer type b (allyl pentaerythritol crosslinked)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36GEL / TRANSDERMAL30 mgExact identifier — unii candidate
6 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / ORAL9120 mgExact identifier — unii candidate
174 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE / ORAL10 mgExact identifier — unii candidate
18 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / RECTAL271 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
carbomer copolymer type b (allyl pentaerythritol crosslinked)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36EMULSION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
carbomer copolymer type b (allyl pentaerythritol crosslinked)CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)809Y72KV36LOTION / TOPICAL29 mgExact identifier — unii candidate
6 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact 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
6ff59f79-4c09-463c-801f-12fdd77938dcfb4d2840-4d45-47db-9323-d73dd9bfa7c92014-10-17WarningsExact identifier
spl id: 6ff59f79-4c09-463c-801f-12fdd77938dc
spl set id: fb4d2840-4d45-47db-9323-d73dd9bfa7c9

Reported adverse events (FAERS/openFDA)#

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