FDA.reportPublic FDA data

1000 Roses ® Daily Shade Facial Lotion SPF 18

Manufacturer
Andalou naturals | Sun Deep Inc
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:02:36

Label at a glance#

Product1000 Roses Daily Shade Facial SPF 18
Active ingredientOCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure10 sections

Indications and 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.

Dosage and administration

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 o...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octocrylene 5%Sunscreen
Octyl Salicylate 5%Sunscreen
Avobenzone 2.5%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Glycerin, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice1, Cetyl Alcohol, Stearic Acid, Stearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil1, C12-15 Alkyl Benzoate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Dimethicone, Lecithin, Carbomer, Malus Domestica Fruit Cell Culture Extract, Xanthan Gum, Fragrance (Parfum), Euterpe Oleracea Fruit Extract1, Aronia Melanocarpa Fruit Extract1, Lycium Barbarum Fruit Extract1, Tocopherol, Ethylhexylglycerin, Panthenol, Allantoin, Magnesium Ascorbyl Phosphate, Vitis Vinifera (Grape) Fruit Cell Extract, Rhododendron Ferrugineum Leaf Cell Culture Extract, Isomalt, Alcohol1, Aspalathus Linearis Leaf Extract1, Camellia Sinensis Leaf Extract1, Hibiscus Sabdariffa Flower Extract1.

1 Certified Organic

Other Information

STORAGE AND HANDLING SECTION

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

Questions

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals,
Petaluma, CA 94952

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUNSCREEN

ANDALOU
NATURALS

1000 Roses®
DAILY SHADE

Facial Lotion
SPF 18

with Alpine Rose Stem Cells
& Vitamins E & C

Broad Spectrum SPF 18

FRUIT
STEM
CELL
SCIENCE®

SENSITIVE

2.7 fl oz / 80 mL

Principal Display Panel - 80 mL Tube Carton
Principal Display Panel - 80 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55560-0103-12025-06-09C16284748780-1ba0f9c33-4611-a910-e053-dadaa90a0b851000 Roses ® Daily Shade Facial Lotion SPF 18
55560-0103-12025-01-30C16284748780-1ba0f9c33-4611-a910-e053-dadaa90a0b851000 Roses ® Daily Shade Facial Lotion SPF 18
55560-0103-12023-02-06C16284748780-1ba0f9c33-4611-a910-e053-dadaa90a0b851000 Roses ® Daily Shade Facial Lotion SPF 18
55560-0103-12021-01-29C16284748780-1ba0f9c33-4611-a910-e053-dadaa90a0b851000 Roses ® Daily Shade Facial Lotion SPF 18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55560-0103-11000 Roses Daily Shade Facial SPF 1880 mL in 1 TUBELOTION807
55560-0103-11000 Roses Daily Shade Facial SPF 181 in 1 CARTONLOTION17

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55560-010355560-0103-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
SUNFLOWER OIL3W1JG795YIIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
HEXYL LAURATE4CG9F9W01QIACT
DIMETHICONE92RU3N3Y1OIACT
SOYBEAN LECITHIN1DI56QDM62IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
APPLEB423VGH5S9IACT
XANTHAN GUMTTV12P4NEEIACT
ACAI46AM2VJ0AWIACT
ARONIA MELANOCARPA FRUIT JUICED2EVP827PJIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PANTHENOLWV9CM0O67ZIACT
ALLANTOIN344S277G0ZIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATEZLW3M94UYAIACT
RHODODENDRON FERRUGINEUM LEAF30NOV1XI0PIACT
ISOMALTS870P55O2WIACT
ALCOHOL3K9958V90MIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
TEA LEAFGH42T47V24IACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1000 Roses Daily Shade Facial SPF 18OCTISALATE, OCTOCRYLENE, AND AVOBENZONEAndalou naturals0923e090-6834-4373-80fe-21f00b8c1c172025-06-09WarningsExact identifier
ndc (package): 55560-0103-1
ndc (product): 55560-0103
ndc11 (package): 55560010301
spl id: bdd0f923-ae26-462b-9e0a-d5d990cfd0a5
spl set id: 0923e090-6834-4373-80fe-21f00b8c1c17

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.