Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 - Golden Hour

Coola Rosilliance Mineral Tinted Face Moisturizer Spf 30 - Golden Hour
SPL v5
SPL
SPL Set ID edfda0f5-0f72-5cc7-e053-2a95a90ae38d
Route
TOPICAL
Published
Effective Date 2022-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.6 g)
Inactive Ingredients
Cucumber Dicaprylyl Carbonate Rosemary Xanthan Gum Orange Rosa X Alba Flower Oil Caprylyl Glycol Safflower Oil Rosa Centifolia Whole Caprylhydroxamic Acid Propanediol Ferric Oxide Yellow Rosa Damascena Flower Aluminum Hydroxide Rosa Gallica Flower Glycerin Commiphora Myrrha Whole Sunflower Seed Sodium Citrate Acai Oil Sunflower Oil Povidone, Unspecified Coco-glycerides Trisodium Ethylenediamine Disuccinate Rice Bran Oil Ferric Oxide Red Ferrosoferric Oxide Water Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Octyldodecyl Oleate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-01

Description

Titanium Dioxide - 5.6%


Medication Information

Warnings and Precautions
  • 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 skin rash occurs.
Description

Titanium Dioxide - 5.6%

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Water, Oryza Sativa (Rice) Bran Oil (ORGANIC), Dicaprylyl Carbonate, Propanediol, Cocoglycerides, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Euterpe Oleracea (Acai) Fruit Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Extract (ORGANIC), Cucumis Sativus (Cucumber) Fruit Extract (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Damascena Leaf Cell Extract, Rosa Gallica Flower Extract, Rosa Centifolia Leaf Cell Extract, Rosa Alba Leaf Cell Extract, Commiphora Myrrha Leaf Cell Extract, Plankton Extract, Glycerin (ORGANIC), Iron Oxides, Caprylyl Glycol, Octyldodecyl Oleate, Aluminum Hydroxide, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Hydrogen Dimethicone, Flavor

Section 51945-4

Section 53413-1

Call 760-940-2125

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide - 5.6%

Section 60561-8
  • Protect this product from excessive heat and direct sun
Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying • At least every 2 hours
  • Sun Protection Measure: 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 10 a.m. to 2 p.m.

    • Wear long-sleeved shirts, pants, hats, and sun glasses.


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings and Precautions (34071-1)
  • 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 skin rash occurs.
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Citrus Aurantium Dulcis (Orange) Fruit Water (ORGANIC), Water, Oryza Sativa (Rice) Bran Oil (ORGANIC), Dicaprylyl Carbonate, Propanediol, Cocoglycerides, Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Euterpe Oleracea (Acai) Fruit Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Extract (ORGANIC), Cucumis Sativus (Cucumber) Fruit Extract (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Damascena Leaf Cell Extract, Rosa Gallica Flower Extract, Rosa Centifolia Leaf Cell Extract, Rosa Alba Leaf Cell Extract, Commiphora Myrrha Leaf Cell Extract, Plankton Extract, Glycerin (ORGANIC), Iron Oxides, Caprylyl Glycol, Octyldodecyl Oleate, Aluminum Hydroxide, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Sodium Citrate, Hydrogen Dimethicone, Flavor

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call 760-940-2125

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide - 5.6%

Section 60561-8 (60561-8)
  • Protect this product from excessive heat and direct sun
Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply: • After 80 minutes of swimming or sweating. • Immediately after towel drying • At least every 2 hours
  • Sun Protection Measure: 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 10 a.m. to 2 p.m.

    • Wear long-sleeved shirts, pants, hats, and sun glasses.


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