1000 Roses®

1000 Roses®
SPL v2
SPL
SPL Set ID 344e0c05-f96d-4c4d-af85-d790f6c29e44
Route
TOPICAL
Published
Effective Date 2017-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Aloe Vera Leaf Water Medium-chain Triglycerides Glycerin Jojoba Oil Polyhydroxystearic Acid (2300 Mw) Polyglyceryl-2 Stearate Sunflower Oil Hydrogenated Castor Oil Dimethicone Magnesium Sulfate, Unspecified Form Sorbitan Sesquioleate Rosa Rugosa Flower Apple Vitis Vinifera Seed Acai Aronia Melanocarpa Fruit Juice Arctostaphylos Uva-ursi Leaf Vaccinium Myrtillus Anthocyanosides European Elderberry Juice Lycium Barbarum Fruit Rosa Canina Fruit Hippophae Rhamnoides Fruit Hyaluronate Sodium Magnolia Officinalis Bark Indian Frankincense Rosa X Damascena Flower Rosa Moschata Oil Pomegranate Seed Oil Borage Seed Oil Ferric Oxide Yellow Starch, Corn White Tea Hibiscus Sabdariffa Flower Tocopherol Phenylethyl Alcohol Ethylhexylglycerin Geraniol Vanillin Geranium Oil, Algerian Type Orange Oil

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn.
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.
  • 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.
  • Children under 6 months: ask a doctor.
Active Ingredient

Zinc Oxide 20%

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

Aloe Barbadensis Leaf Juice

Certified Organic/Organic
, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil
, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil
, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive Berry Complex
, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Rosa Damascena (Rose) Flower Distillate
, Rosa Canina (Rosehip) Fruit Oil
, Punica Granatum (Pomegranate) Seed Oil
, Borago Officinalis (Borage) Seed Oil
, Iron Oxides, Zea Mays (Corn) Starch
, Camellia Sinensis (White Tea) Leaf Extract
Fair Trade/Biologique
, Hibiscus Sabdariffa Flower Extract
, Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil
, Citrus Aurantium Dulcis (Orange) Peel Oil

Principal Display Panel 58 Ml Tube Carton

NEW LOOK

ANDALOU

NATURALS

NON

GMO

CC

1000 Roses®

COLOR +

CORRECT

Sheer Nude

SPF 30

with Rose Stem Cells

Soothing Resilience

Broad Spectrum Protection

FRUIT

STEM

CELL

SCIENCE
®

SENSITIVE

NPN 80051204

2 fl oz e 58 mL


Structured Label Content

Uses
  • Helps prevent sunburn.
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.
  • 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.
  • Children under 6 months: ask a doctor.
Active Ingredient

Zinc Oxide 20%

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

Aloe Barbadensis Leaf Juice

Certified Organic/Organic
, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil
, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil
, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive Berry Complex
, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Rosa Damascena (Rose) Flower Distillate
, Rosa Canina (Rosehip) Fruit Oil
, Punica Granatum (Pomegranate) Seed Oil
, Borago Officinalis (Borage) Seed Oil
, Iron Oxides, Zea Mays (Corn) Starch
, Camellia Sinensis (White Tea) Leaf Extract
Fair Trade/Biologique
, Hibiscus Sabdariffa Flower Extract
, Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower Oil
, Citrus Aurantium Dulcis (Orange) Peel Oil

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

NEW LOOK

ANDALOU

NATURALS

NON

GMO

CC

1000 Roses®

COLOR +

CORRECT

Sheer Nude

SPF 30

with Rose Stem Cells

Soothing Resilience

Broad Spectrum Protection

FRUIT

STEM

CELL

SCIENCE
®

SENSITIVE

NPN 80051204

2 fl oz e 58 mL


Advanced Ingredient Data


Raw Label Data

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