Ultra Sheer Daily Defense Facial Spf 18 Lotion
FDA Label NDC 55560-3331

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Andalou Naturals for the product Ultra Sheer Daily Defense Facial Spf 18 (NDC 55560-3331). 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, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Andalou Naturals,
Petaluma, CA 94954 USA

Otc - Purpose

Active IngredientsPurpose
Homosalate 12.0%Sunscreen
Octisalate 4.0%Sunscreen
Avobenzone 3.0%Sunscreen

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

  • 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 or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Daily, alone or under make-up.
  • Apply liberally 15-30 minutes before sun exposure and as needed.
  • Reapply at least every 2 hours.
  • 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.

Inactive Ingredients

Aloe Barbadensis Leaf Juice

Certified Organic

, Purified Water (Aqua), Vegetable Glycerin, Glyceryl Stearate, Stearic Acid, Sorbitan Sesquioleate, Stearyl Alcohol, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil, Fruit Stem Cells (Malus Domestica, Solar Vitis) and BioActive Berry Complex, Panthenol, Allantoin, Tocopherol, Sodium Hyaluronate, Resveratrol, Ubiquinone (CoQ10), Magnesium Ascorbyl Phosphate (Vitamin C), Dipotassium Glycyrrhizinate (Licorice) Root Extract, Laminaria Digitata (Kelp) Extract, Chamomilla Recutita (Chamomile) Flower Extract, Calendula Officinalis Flower Extract, Rosa Canina (Rosehip) Fruit Oil, Camellia Sinensis (White Tea) Leaf Extract

Fair Trade Ingredient

, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Tangerina (Tangerine) Peel Oil, Citrus Aurantium Dulcis (Orange) Peel Oil

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Questions

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

Principal Display Panel - 80 Ml Tube Box

ANDALOU
NATURALS

Ultra Sheer
DAILY DEFENSE

Facial Lotion
SPF 18

with Resveratrol Q10
Youthful Vitality

Broad Spectrum Protection

FRUIT
STEM
CELL
SCIENCE®

AGE DEFYING

2.7 fl oz / 80 mL

Principal Display Panel (80 mL Tube Box)

Principal Display Panel (80 mL Tube Box)

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