FDA.reportPublic FDA data

CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen

Manufacturer
Cosmetic Solutions LLC
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:00

Label at a glance#

ProductCaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen
Active ingredientOctinoxate, Zinc Oxide
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply to all skin exposed to the sun. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. If swimming or sweating, use water resistant sunscreen. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. Decrease this risk, by regularly using sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures in...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Zinc Oxide 10.0%}

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

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 each of children.

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply to all skin exposed to the sun. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. If swimming or sweating, use water resistant sunscreen.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Decrease this risk, by regularly using sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, ArachidylAlcohol, PolyhydroxystearicAcid, Coco-Glucoside, HydroxyethylAcrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, PhenethylAlcohol, Caprylyl Glycol.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 60 G Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cara Gala

Botanical
Defense
Day Cream

Broad Spectrum
SPF 30
Sunscreen

SUNSCREEN

NET WT. 2 OZ. (60G)

PRINCIPAL DISPLAY PANEL - 60 G Tube Carton
PRINCIPAL DISPLAY PANEL - 60 G Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-0302-12024-01-30C16284748780-11030e365-30d9-111a-e063-dadaa90a10e2CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-0302-1CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen60 mL in 1 TUBELOTION601
66163-0302-1CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-0302CARAGALA - BOTANICAL DEFENSE DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN (OCTINOXATE AND ZINC OXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 2 package rows20220401_9000fa5a-3c8a-479b-95e8-2abfdabb544f.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-030266163-0302-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Butyloctyl Salicylate2EH13UN8D3IACT
GlycerinPDC6A3C0OXIACT
Dimethicone92RU3N3Y1OIACT
Styrene/Acrylamide Copolymer (500000 MW)5Z4DPO246AIACT
Cocoyl Caprylocaprate8D9H4QU99HIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Carthamus Tinctorius Seed Oleosomes9S60Q72309IACT
Cardamom8BC4CUT4JLIACT
Aloe Vera LeafZY81Z83H0XIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Perilla Frutescens Seed8M62PUD356IACT
AppleB423VGH5S9IACT
Santalum Album Seed7RZT0U509YIACT
Green Tea LeafW2ZU1RY8B0IACT
Chamaemelum Nobile FlowerO2T154T6OGIACT
Cananga Odorata Flower76GTF6Z97MIACT
Orange PeelTI9T76XD44IACT
MuskmelonZV095H5633IACT
Jasminum Officinale Flower0Q8K841432IACT
Lavandula Angustifolia Subsp. Angustifolia Flowering Top9YT4B71U8PIACT
Raspberry4N14V5R27WIACT
Polygonum Aviculare TopZCD6009IUFIACT
Propanediol5965N8W85TIACT
Cetostearyl Alcohol2DMT128M1SIACT
Pentylene Glycol50C1307PZGIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Coco GlucosideICS790225BIACT
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
Docosanol9G1OE216XYIACT
Xanthan GumTTV12P4NEEIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Arachidyl Glucoside6JVW35JOOJIACT
Phenylethyl AlcoholML9LGA7468IACT
Caprylyl Glycol00YIU5438UIACT

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
591bc536-f78a-4106-9654-848b2a7ed9579000fa5a-3c8a-479b-95e8-2abfdabb544f2022-03-08WarningsExact identifier
spl id: 591bc536-f78a-4106-9654-848b2a7ed957
spl set id: 9000fa5a-3c8a-479b-95e8-2abfdabb544f

Reported adverse events (FAERS/openFDA)#

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