Caragala - Botanical Defense Day Cream Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 66163-0302

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Caragala - Botanical Defense Day Cream Broad Spectrum Spf 30 Sunscreen (NDC 66163-0302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

Active Ingredients

Octinoxate 7.5%, Zinc Oxide 10.0%}

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (60 G Tube Carton)

Principal Display Panel (60 G Tube Carton)

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