CARAGALA - BOTANICAL DEFENSE DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide lotion 
Cosmetic Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen

DRUG FACTS:

ACTIVE INGREDIENTS

Octinoxate 7.5%, Zinc Oxide 10.0%}

Purpose

Sunscreen

USES

Helps prevent sunburn.

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of each of children.

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

DIRECTIONS

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:

Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS

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

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

PRINCIPAL DISPLAY PANEL - 60 G Tube Carton

Cara Gala

Botanical
Defense
Day Cream

Broad Spectrum
SPF 30
Sunscreen

SUNSCREEN

NET WT. 2 OZ. (60G)

PRINCIPAL DISPLAY PANEL - 60 G Tube Carton
CARAGALA - BOTANICAL DEFENSE DAY CREAM BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-0302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethicone (UNII: 92RU3N3Y1O)  
Styrene/Acrylamide Copolymer (500000 MW) (UNII: 5Z4DPO246A)  
Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
Cardamom (UNII: 8BC4CUT4JL)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Perilla Frutescens Seed (UNII: 8M62PUD356)  
Apple (UNII: B423VGH5S9)  
Santalum Album Seed (UNII: 7RZT0U509Y)  
Green Tea Leaf (UNII: W2ZU1RY8B0)  
Chamaemelum Nobile Flower (UNII: O2T154T6OG)  
Cananga Odorata Flower (UNII: 76GTF6Z97M)  
Orange Peel (UNII: TI9T76XD44)  
Muskmelon (UNII: ZV095H5633)  
Jasminum Officinale Flower (UNII: 0Q8K841432)  
Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
Raspberry (UNII: 4N14V5R27W)  
Polygonum Aviculare Top (UNII: ZCD6009IUF)  
Propanediol (UNII: 5965N8W85T)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Pentylene Glycol (UNII: 50C1307PZG)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Coco Glucoside (UNII: ICS790225B)  
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
Docosanol (UNII: 9G1OE216XY)  
Xanthan Gum (UNII: TTV12P4NEE)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Phenylethyl Alcohol (UNII: ML9LGA7468)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-0302-11 in 1 CARTON04/01/2022
160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2022
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 3/2022
Document Id: 591bc536-f78a-4106-9654-848b2a7ed957
Set id: 9000fa5a-3c8a-479b-95e8-2abfdabb544f
Version: 1
Effective Time: 20220308
 
Cosmetic Solutions LLC