FDA.reportPublic FDA data

Coral Isle SPF 50 Mineral Lotion

Manufacturer
Rocky Mountain | Derma Care Research Labs, LLC | Derma Care Research Labs
Effective date
2026-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-07-17 21:35:55

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 4.5%, 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 49757-114-02

labellabel

Coral Isle SPF 50 Mineral Sunscreen, 6 oz, NDC 49756-114-06

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130754018850200GTIN-13: 0754018850200
EAN-13: 0754018850200
GTIN-12: 754018850200
UPC-A: 754018850200
GTIN storage (14 digits): 00754018850200		RKY-C5LM2 copy.jpg
BarcodeEAN-130754018850606GTIN-13: 0754018850606
EAN-13: 0754018850606
GTIN-12: 754018850606
UPC-A: 754018850606
GTIN storage (14 digits): 00754018850606		RKY-C5LM6 copy.jpg
QR code linkQR Codermsunscreen.com/product-category/coral-isles/RKY-C5LM6 copy.jpg, RKY-C5LM2 copy.jpg

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
49757-11449757-114-06, 49757-114-02

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 OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
ndc (package): 49757-114-06
ndc (package): 49757-114-02
ndc (product): 49757-114
ndc11 (package): 49757011402
ndc11 (package): 49757011406
spl id: 5515f562-62da-c6ee-e063-6294a90a9ea6
spl set id: 5515f562-62d9-c6ee-e063-6294a90a9ea6

Reported adverse events (FAERS/openFDA)#

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