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

CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

CaraGala - Botanical Defense Day Cream Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• 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

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-0302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-0302-1	1 in 1 CARTON	04/01/2022
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2022

Labeler - Cosmetic Solutions LLC (807907928)