Ultra Sheer Daily Defense Facial Spf 18

Ultra Sheer Daily Defense Facial Spf 18
SPL v5
SPL
SPL Set ID 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (120 mg) Octisalate (40 mg) Avobenzone (30 mg)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Sorbitan Sesquioleate Glyceryl Monostearate Stearyl Alcohol Phenoxyethanol Cetyl Alcohol Stearic Acid Alkyl (c12-15) Benzoate Glyceryl Stearate Citrate Apple Soybean Lecithin Xanthan Gum Carbomer Homopolymer, Unspecified Type Panthenol Tocopherol Ethylhexylglycerin Allantoin Vitis Vinifera High Tannin Cultivar Fruit Cell Lysate 1,2-hexanediol Hyaluronate Sodium Acai Aronia Melanocarpa Fruit Juice Lycium Barbarum Fruit Tea Leaf Resveratrol Potassium Sorbate Magnesium Ascorbyl Phosphate Isomalt Alcohol Aspalathus Linearis Leaf Hibiscus Sabdariffa Flower Calendula Officinalis Flower Ubidecarenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Drug Facts


Medication Information

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.
Section 55105-1
Active Ingredients Purpose
Homosalate 12.0% Sunscreen
Octyl Salicylate 4.0% Sunscreen
Avobenzone 3.0% 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.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice

Certified Organic Ingredient
, Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract
, Aronia Melanocarpa (Black Chokeberry) Fruit Extract
, Lycium Barbarum (Goji) Fruit Extract
, Camellia Sinensis (White Tea) Leaf Extract
, Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol
, Aspalathus Linearis (Rooibos) Leaf Extract
, Hibiscus Sabdariffa (Roselle) Flower Extract
, Calendula Officinalis Flower Extract
, Ubiquinone (Co-Enzyme Q10).

Principal Display Panel 80 Ml Tube Carton

SUNSCREEN

ANDALOU

NATURALS

Ultra Sheer

DAILY DEFENSE

Facial Lotion

SPF 18

with Resveratrol + CoQ10

+ Hyaluronic Acid

Broad Spectrum SPF 18

FRUIT

STEM

CELL

SCIENCE®

AGE DEFYING

2.7 fl oz / 80 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.
Section 55105-1 (55105-1)
Active Ingredients Purpose
Homosalate 12.0% Sunscreen
Octyl Salicylate 4.0% Sunscreen
Avobenzone 3.0% 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.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Aqua/Water/Eau, Glycerin, Aloe Barbadendis (Aloe Vera) Leaf Juice

Certified Organic Ingredient
, Sorbitan Sesquioleate, Glyceryl Stearate, Natural Fragrance, Stearyl Alcohol, Phenoxyethanol, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Malus Domestica (Apple) Fruit Cell Culture, Lecithin, Xanthan Gum, Carbomer, Panthenol (Pro-Vitamin B5), Malus Domestica (Apple) Fruit Cell Culture Extract, Tocopherol (Vitamin E), Ethylhexylglycerin, Allantoin, Vitis Vinifera (Grape) Callus Culture Extract, 1,2-Hexanediol, Sodium Hyaluronate, Euterpe Oleracea (Açai) Fruit Extract
, Aronia Melanocarpa (Black Chokeberry) Fruit Extract
, Lycium Barbarum (Goji) Fruit Extract
, Camellia Sinensis (White Tea) Leaf Extract
, Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol
, Aspalathus Linearis (Rooibos) Leaf Extract
, Hibiscus Sabdariffa (Roselle) Flower Extract
, Calendula Officinalis Flower Extract
, Ubiquinone (Co-Enzyme Q10).

Principal Display Panel 80 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton)

SUNSCREEN

ANDALOU

NATURALS

Ultra Sheer

DAILY DEFENSE

Facial Lotion

SPF 18

with Resveratrol + CoQ10

+ Hyaluronic Acid

Broad Spectrum SPF 18

FRUIT

STEM

CELL

SCIENCE®

AGE DEFYING

2.7 fl oz / 80 mL


Advanced Ingredient Data


Raw Label Data

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