FDA.reportPublic FDA data

Coconut Caliente - SPF 50 Mineral Lotion 6 fl oz

Manufacturer
Coconut Caliente Costa Rica LLC | Inspec Solutions
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:12

Label at a glance#

ProductZinc Oxide 20.00%
Active ingredientZINC OXIDE
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 ingredient                    Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20% ......................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.

Ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexancdiol
Aloc Barbadcnsis Lcaf Extract
Aloe Barbadensis Leaf Juice
Ascorhvl Palmitate
Butylcnc Glycol
Butyloctyl Salicylate
ButyrosDerrnum Parkii (Shea) Butler
Caprylic/Capric Triglivceride
Cetearvl Olivate
Daucus Carota Sativa (Carrot) Rioot Extract
Dicaprylyl Carbonatc
Dimethicone
Ethylhexyl Methoxycrvlene
.bthylhexylglvccrin
Iragrancc
Helianthus Amuus (Sunllorver) Seed Oil
Hydrogcnatecl Castor Oil
Isoplorryl N,lyristate
Magncsium Sulfate
Mansifera lndica (Mar.rgo) Seed Butter
Mineral Oil
Niacinamiclc
Phenoxyethanol
Phospholipids
Polvslvceiryl-3 .Polyr icinoleate
Polyhydroxystearic Acid
Rctinyl Palmitate
Ilubus ldaeus (Red Raspbern) Seccl Oil
Sodiunr llyaluronate
Sorbitan Olcate
Sorbitan Olivate
Synthctic Bccsu,ax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeflowcode.com/p/E7RNrcTg1Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85033-001-04Zinc Oxide 20.00%177 mL in 1 TUBELOTION1772

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85033-00185033-001-04

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
ALOEV5VD430YW9IACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEA BUTTERK49155WL9YIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CETEARYL OLIVATE58B69Q84JOIACT
DAUCUS CAROTA SATIVA (CARROT) JUICEQXF936IX43IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FRAGRANCE ESC 10-740QH92QT9LWRIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MAGNESIUM SULFATEDE08037SABIACT
MANGO SEED OILK8LOR30915IACT
MINERAL OILT5L8T28FGPIACT
NIACINAMIDE25X51I8RD4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BOVINE LUNG PHOSPHOLIPIDS ADULTEA3D6UW549IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
RUBUS IDAEUS (RASPBERRY) SEED OIL9S8867952AIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SORBITAN OLEATE06XEA2VD56IACT
SORBITAN OLIVATEMDL271E3GRIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Zinc Oxide 20.00%SPF 50 MINERALCoconut Caliente Costa Rica LLC388f1e01-0feb-4c94-88a7-13c81368c6c82026-05-07WarningsExact identifier
ndc (package): 85033-001-04
ndc (product): 85033-001
ndc11 (package): 85033000104
spl id: 514002f3-7bef-9313-e063-6394a90a4c3e
spl set id: 388f1e01-0feb-4c94-88a7-13c81368c6c8

Reported adverse events (FAERS/openFDA)#

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