1000 Roses Daily Shade Facial Spf 18 Lotion
FDA Label NDC 55560-0103

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 1000 Roses Daily Shade Facial Spf 18 (NDC 55560-0103). 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 otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
Octisalate 5.0%Sunscreen
Octocrylene 5.0%Sunscreen
Avobenzone 2.5%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.

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, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Plant Stem Cells (Alpine Rose, Malus Domestica, Solar Vitis) and BioActive 8 Berry Complex, Dimethicone, Lecithin, Tocopherol, Soothing Complex: [Sodium Hyaluronate, Magnolia Officinalis Bark Extract, Boswellia Serrata (Boswellin) Extract], Panthenol, Allantoin, Rosa Damascena (Rose) Flower Distillate, Magnesium Ascorbyl Phosphate (Vitamin C), Chamomilla Recutita (Chamomile) Flower Extract, Calendula Officinalis Flower Extract, Rosa Canina (Rosehip) Fruit Oil, Punica Granatum (Pomegranate) Seed Oil, Camellia Sinensis (White Tea) Leaf Extract

Fair Trade Ingredients

, Aspalathus Linearis (Rooibos) Extract, Hibiscus Sabdariffa Flower Extract, Phenethyl Alcohol, Ethylhexylglycerin, Rose Isolates, Vanilla Isolates, Pelargonium Graveolens (Rose Geranium) Flower 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

Other

Dist. by Andalou Naturals
Novato, CA 94945 USA

Principal Display Panel - 80 Ml Tube Carton

NEW LOOK

ANDALOU
NATURALS

NON
GMO

1000 Roses®
DAILY SHADE

Facial Lotion
SPF 18

with Rose Stem Cells
Soothing Resilience

Broad Spectrum Protection

FRUIT
STEM
CELL

SCIENCE®

SENSITIVE

2.7 fl oz e 80 mL

Principal Display Panel (80 mL Tube Carton)

Principal Display Panel (80 mL Tube Carton)

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