FDA.reportPublic FDA data

ULTRA SHEER DAILY DEFENSE FACIAL SPF 18

Manufacturer
Andalou naturals | Sun Deep Inc
Effective date
2025-06-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:02:49

Label at a glance#

ProductULTRA SHEER DAILY DEFENSE FACIAL SPF 18
Active ingredientHOMOSALATE, OCTISALATE, 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
Homosalate 12.0%Sunscreen
Octyl Salicylate 4.0%Sunscreen
Avobenzone 3.0%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, Aloe Barbadendis (Aloe Vera) Leaf Juice1, 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 Extract1, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Camellia Sinensis (White Tea) Leaf Extract1, Pichia/Resveratrol Ferment Extract, Potassium Sorbate, Magnesium Ascorbyl Phosphate (Vitamin C), Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol1, Aspalathus Linearis (Rooibos) Leaf Extract1, Hibiscus Sabdariffa (Roselle) Flower Extract1, Calendula Officinalis Flower Extract1, Ubiquinone (Co-Enzyme Q10).

1 Certified Organic Ingredient

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
165 1st St., Petaluma, CA 94952 USA

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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
55560-3331-12025-06-11C16284748780-1f386c649-b4b3-0266-e053-dadaa90a7c1aULTRA SHEER DAILY DEFENSE FACIAL SPF 18
55560-3331-12025-01-30C16284748780-1f386c649-b4b3-0266-e053-dadaa90a7c1aULTRA SHEER DAILY DEFENSE FACIAL SPF 18
55560-3331-12023-02-02C16284748780-1f386c649-b4b3-0266-e053-dadaa90a7c1aULTRA SHEER DAILY DEFENSE FACIAL SPF 18
55560-3331-12023-01-30C16284748780-1f386c649-b4b3-0266-e053-dadaa90a7c1aULTRA SHEER DAILY DEFENSE FACIAL SPF 18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55560-3331-1ULTRA SHEER DAILY DEFENSE FACIAL SPF 1880 mL in 1 TUBELOTION805
55560-3331-1ULTRA SHEER DAILY DEFENSE FACIAL SPF 181 in 1 BOXLOTION15

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55560-333155560-3331-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARYL ALCOHOL2KR89I4H1YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
APPLEB423VGH5S9IACT
SOYBEAN LECITHIN1DI56QDM62IACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PANTHENOLWV9CM0O67ZIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALLANTOIN344S277G0ZIACT
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATEZLW3M94UYAIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ACAI46AM2VJ0AWIACT
ARONIA MELANOCARPA FRUIT JUICED2EVP827PJIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
TEA LEAFGH42T47V24IACT
RESVERATROLQ369O8926LIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
ISOMALTS870P55O2WIACT
ALCOHOL3K9958V90MIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
UBIDECARENONEEJ27X76M46IACT

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
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18HOMOSALATE, OCTISALATE, AND AVOBENZONEAndalou naturals0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f2025-06-11WarningsExact identifier
ndc (package): 55560-3331-1
ndc (product): 55560-3331
ndc11 (package): 55560333101
spl id: 258b9705-1493-4410-9bb6-49cf7977eea8
spl set id: 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f

Reported adverse events (FAERS/openFDA)#

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