FDA.reportPublic FDA data

Coral Isle SPF 50 Mineral Lotion

Manufacturer
Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2026-03-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:50:21

Label at a glance#

ProductCoral Isle SPF 50 Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including: limit time in the sun, especial...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.4%, Zinc Oxide 4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION 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.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INDICATIONS & USAGE 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 n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, ethylhexyl palmitate, C12-15 alkyl benzoate, styrene/acrylates copolymer, glycerin, sorbitan olivate, cetyl PEG/PPG-10/1 dimethicone, dimethicone, aluminum starch octenylsuccinate, sodium chloride, silica, aloe barbadensis leaf extract, cucumis sativus (cucumber) fruit extract, mentha piperita (peppermint) leaf extract, punica granatum fruit juice, oryza sativa (rice) bran water, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grade) seed extract, camellia sinensis leaf extract, ethylhexylglycerin, propanediol, disodium EDTA, phenoxyethanol, alumina, hydrogen dimethicone

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coral Isle SPF 50 Mineral Sunscreen, 2 oz, NDC 72839-114-02

LABELLABELlabellabel

LABELLABEL

Coral Isle Baby SPF 50 Mineral, 2 oz, NDC 72839-114-12

LabelLabel

Coral Isle SPF 50 Mineral Sunscreen, 6 oz, NDC 72839-114-06

LABELLABEL

Coral Isle SPF 50 Baby Mineral Sunscreen, 6 oz, NDC 72839-114-16

LABELLABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130054018850607GTIN-13: 0054018850607
EAN-13: 0054018850607
GTIN-12: 054018850607
UPC-A: 054018850607
GTIN storage (14 digits): 00054018850607		Coral Isle SPF 50 6oz.jpg
BarcodeEAN-130054018850652GTIN-13: 0054018850652
EAN-13: 0054018850652
GTIN-12: 054018850652
UPC-A: 054018850652
GTIN storage (14 digits): 00054018850652		Coral Isle SPF 50 Baby 6 oz.jpg
BarcodeEAN-130754018850200GTIN-13: 0754018850200
EAN-13: 0754018850200
GTIN-12: 754018850200
UPC-A: 754018850200
GTIN storage (14 digits): 00754018850200		PSYS-392926-NJ-002 9.19.23 copy.jpg
BarcodeEAN-130754018850255GTIN-13: 0754018850255
EAN-13: 0754018850255
GTIN-12: 754018850255
UPC-A: 754018850255
GTIN storage (14 digits): 00754018850255		PSYS-392931-NJ-002.jpg
QR code linkQR Codermsunscreen.com/product-category/coral-isles/Coral Isle SPF 50 Baby 6 oz.jpg, Coral Isle SPF 50 6oz.jpg, PSYS-392926-NJ-002 9.19.23 copy.jpg, PSYS-392931-NJ-002.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-114-02Coral Isle SPF 50 Mineral Sunscreen57 g in 1 BOTTLELOTION574
72839-114-06Coral Isle SPF 50 Mineral Sunscreen170 g in 1 TUBELOTION1704
72839-114-12Coral Isle SPF 50 Mineral Sunscreen57 g in 1 TUBELOTION574
72839-114-16Coral Isle SPF 50 Mineral Sunscreen170 g in 1 BOTTLELOTION1704

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-11472839-114-06, 72839-114-12, 72839-114-02, 72839-114-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYL PALMITATE2865993309IACT
EDETATE DISODIUM7FLD91C86KIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
GLYCERINPDC6A3C0OXIACT
ZINC OXIDESOI2LOH54ZACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
SORBITAN OLIVATEMDL271E3GRIACT
DIMETHICONE 200RGS4T2AS00IACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
SODIUM CHLORIDE451W47IQ8XIACT
ROSEMARYIJ67X351P9IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALUMINUM OXIDELMI26O6933IACT
ALOE VERA LEAFZY81Z83H0XIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
CUCUMBERYY7C30VXJTIACT
POMEGRANATE JUICE99S671U9KBIACT
RICE BRAN, DEFATTEDH6597RO5A2IACT
PROPANEDIOL5965N8W85TIACT

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
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aafab44-0481-2a22-e063-6294a90abef22026-03-17WarningsExact identifier
ndc (package): 72839-114-02
ndc (package): 72839-114-16
ndc (package): 72839-114-12
ndc (package): 72839-114-06
ndc (product): 72839-114
ndc11 (package): 72839011412
ndc11 (package): 72839011402
ndc11 (package): 72839011416
ndc11 (package): 72839011406
spl id: 4d3e875f-b912-3fb8-e063-6394a90a7bd8
spl set id: 0aafab44-0481-2a22-e063-6294a90abef2

Reported adverse events (FAERS/openFDA)#

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