FDA.reportPublic FDA data

SPF 50 Spray - Coconut Caliente (IS0335-COF)

Manufacturer
Coconut Caliente Costa Rica LLC | Inspec Solutions
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:34

Label at a glance#

ProductSPF 30 Sunscreen
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply evenly to face and neck 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 value of 15 or higher and other sun protection measures includin...

Label contents#

Full prescribing information#

Active Ingredients                     Purpose

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%                          Sunscreen
Octisalate 5%                              Sunscreen
Avobenzone 3%                          Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly to face and neck 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 value of 15 or higher and other sun
protection measures including: Limit time in the sun, especially from
10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses.
. Children under 6 months: Ask a doctor.

Warnings For external use only.

WARNINGS SECTION

Do not useon damaged or broken skin.
When using this product• keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor ifrash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Aloe Barbadensis Leaf Extract
Ascorbyl Palmitate
Butyloctyl Salicylate
Daucus Carota Sativa (Carrot) Root Extract
Fragrance
Helianthus Annuus (Sunflower) Seed Oil
Mangifera Indica (Mango) Seed Butter
Mineral Oil
Oryza Sativa (Rice) Bran Oil
Phospholipids
Polyester-8
Retinyl Palmitate
Rubus Idaeus (Red Raspberry) Seed Oil
Sodium Hyaluronate
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85033-003-04SPF 30 Sunscreen117 mL in 1 CANSPRAY1172

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85033-00385033-003-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DAUCUS CAROTA SATIVA (CARROT) JUICEQXF936IX43IACT
FRAGRANCE ESC 10-740QH92QT9LWRIACT
SUNFLOWER OIL3W1JG795YIIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
MINERAL OILT5L8T28FGPIACT
ORYZA SATIVA (RICE) GERM OILD4H5GGS5JFIACT
BOVINE LUNG PHOSPHOLIPIDS ADULTEA3D6UW549IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
RETINYL PALMITATE1D1K0N0VVCIACT
RASPBERRY SEED OIL9S8867952AIACT
SODIUM HYALURONATEYSE9PPT4THIACT
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
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
SPF 30 SunscreenHOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3%Coconut Caliente Costa Rica LLCaf56f16a-2643-4bfc-9e05-dfba79cdab8a2026-05-08WarningsExact identifier
ndc (package): 85033-003-04
ndc (product): 85033-003
ndc11 (package): 85033000304
spl id: 514f5ab2-066a-1e03-e063-6294a90ae5b6
spl set id: af56f16a-2643-4bfc-9e05-dfba79cdab8a

Reported adverse events (FAERS/openFDA)#

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