1000 Roses®

1000 Roses®
SPL v6
SPL
SPL Set ID 9314e4fc-ba3e-480e-a005-b8928130ed70
Route
TOPICAL
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Polyglyceryl-3 Pentaricinoleate Magnesium Sulfate, Unspecified Form Glycerin Sorbitan Sesquioleate Hydrogenated Castor Oil Hydrogenated Methyl Abietate Stearyl/octyldodecyl Citrate Crosspolymer Caprylhydroxamic Acid Glyceryl Monocaprylate Rhododendron Ferrugineum Leaf Apple Vitis Vinifera High Tannin Cultivar Fruit Cell Lysate Hyaluronate Sodium Jojoba Oil Sunflower Oil Aronia Melanocarpa Fruit Juice Lycium Barbarum Fruit Acai Tea Leaf Isomalt Soybean Lecithin Tocopherol Galactoarabinan Xanthan Gum Sodium Benzoate Ethylhexylglycerin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash or irritation develops and lasts.
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Warnings
  • For external use only.
Questions

Call (888) 898-6955 or visit www.Andalou.com

Directions
  • Daily, alone or under make-up.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
  • Use water resistant sunscreen if swimming or sweating.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures. 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long sleeve shirts, pants and sunglasses.
Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Non Medicinal Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Magnesium Sulfate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Hydrogenated Methyl Abietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Caprylhydroxamic Acid, Glyceryl Caprylate, Rhododendron Ferrugineum (Alpine Rose) Leaf Cell Culture Extract, Malus Domestica (Apple) Fruit Cell Culture Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Hyaluronate, Simmondsia Chinensis (Jojoba) Seed Oil

Certified Organic Ingredient.
, Helianthus Annuus (Sunflower) Seed Oil
, Aronia Melanocarpa (Black Chokeberry) Fruit Extract
, Lycium Barbarum (Goji) Fruit Extract
, Euterpe Oleracea (Açai) Fruit Extract
, Camellia Sinensis (Tea) Leaf Extract
, Isomalt, Soy Lecithin, Tocopherol, Galactoarabinan, Xanthan Gum, Sodium Benzoate, Ethylhexylglycerin, Natural Fragrance, Iron Oxides (CI 77491, CI 77492, CI 77499).

Principal Display Panel 58 Ml Tube Carton

MINERAL SUNSCREEN

ANDALOU

NATURALS

CC

1000 Roses®

COLOR + CORRECT

Sheer Tan

SPF 30

Alpine Rose Stem Cells +

Hyaluronic Acid + Vitamin E

Broad Spectrum SPF 30

FRUIT

STEM

CELL

SCIENCE®

SENSITIVE

NPN 80051191

2 fl oz / 58 mL


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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash or irritation develops and lasts.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Purpose

Sunscreen

Warnings
  • For external use only.
Questions

Call (888) 898-6955 or visit www.Andalou.com

Directions
  • Daily, alone or under make-up.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
  • Use water resistant sunscreen if swimming or sweating.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures. 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long sleeve shirts, pants and sunglasses.
Active Ingredient

Zinc Oxide 20%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Non Medicinal Ingredients

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Polyglyceryl-3 Polyricinoleate, Magnesium Sulfate, Glycerin, Sorbitan Sesquioleate, Hydrogenated Castor Oil, Hydrogenated Methyl Abietate, Stearyl/Octyldodecyl Citrate Crosspolymer, Caprylhydroxamic Acid, Glyceryl Caprylate, Rhododendron Ferrugineum (Alpine Rose) Leaf Cell Culture Extract, Malus Domestica (Apple) Fruit Cell Culture Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Sodium Hyaluronate, Simmondsia Chinensis (Jojoba) Seed Oil

Certified Organic Ingredient.
, Helianthus Annuus (Sunflower) Seed Oil
, Aronia Melanocarpa (Black Chokeberry) Fruit Extract
, Lycium Barbarum (Goji) Fruit Extract
, Euterpe Oleracea (Açai) Fruit Extract
, Camellia Sinensis (Tea) Leaf Extract
, Isomalt, Soy Lecithin, Tocopherol, Galactoarabinan, Xanthan Gum, Sodium Benzoate, Ethylhexylglycerin, Natural Fragrance, Iron Oxides (CI 77491, CI 77492, CI 77499).

Principal Display Panel 58 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton)

MINERAL SUNSCREEN

ANDALOU

NATURALS

CC

1000 Roses®

COLOR + CORRECT

Sheer Tan

SPF 30

Alpine Rose Stem Cells +

Hyaluronic Acid + Vitamin E

Broad Spectrum SPF 30

FRUIT

STEM

CELL

SCIENCE®

SENSITIVE

NPN 80051191

2 fl oz / 58 mL


Advanced Ingredient Data


Raw Label Data

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