FDA.reportPublic FDA data

ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30

Manufacturer
Andalou naturals | Bell International Laboratories
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:32

Label at a glance#

ProductANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30
Active ingredientZINC OXIDE
Label structure11 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

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor. Use daily or alone under makeup. 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 value of 15 or higher...

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.7%

Purpose

OTC - PURPOSE SECTION

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 occurs.

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

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor.
  • Use daily or alone under makeup.

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 value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Cocos Nucifera (Coconut) Oil, Butyloctyl Salicylate, Tetradecane, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Ectoin, Arachidyl Alcohol, Caprylyl Glycol, Diheptyl Succinate, Coco-Glucoside, Xanthan Gum, Calcium Sodium Borosilicate, Helianthus Annuus (Sunflower) Seed Oil, Behenyl Alcohol, Capryloyl Glycerin/Sebacic Acid Copolymer, Bisabolol1, Citric Acid, Arachidyl Glucoside, Sodium Gluconate, Glycerin, Caprylhydroxamic Acid, Tocopherol (Vitamin E), Beta-Sitosterol, Squalene, Aloe Barbadensis (Aloe Vera) Leaf Juice1, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Isomalt, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Malus Domestica (Apple) Fruit Cell Culture Extract, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Camellia Sinensis (Tea) Leaf Extract1, Euterpe Oleracea (Açai) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Spirulina Maxima Extract, sr-Hydrozoan Polypeptide-1, Soy Lecithin, Sodium Benzoate, Vitis Vinifera (Grape) Fruit Cell Extract, Natural Fragrance, Linalool 2 , Citronellol 2 , Hexyl Cinnamal 2 , Limonene 2

1 Certified Organic,

2 Component of Natural Fragrance.

Questions or Comments?

OTC - QUESTIONS SECTION

Call (415) 446-9470.

SPL UNCLASSIFIED SECTION

Dist. by Andalou Naturals,
Petaluma, CA 94954.

PRINCIPAL DISPLAY PANEL - 80 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MINERAL
SUNSCREEN

ANDALOU
NATURALS

RECOMMENDED
Skin
Cancer
Foundation
DAILY USE

DAILY SHADE +
Blue Light Defense
Facial Lotion
Hyaluronic Acid + Ectoin

SPF 30
Broad Spectrum SPF 30

FRUIT
STEM
CELL
SCIENCE®

DEEP
HYDRATION

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55560-2201-12025-06-19C16284748780-12cef2736-7db2-d83d-e063-dadaa90ab31fANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30
55560-2201-12025-01-30C16284748780-12cef2736-7db2-d83d-e063-dadaa90ab31fANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55560-2201-1ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 3080 mL in 1 TUBELOTION803
55560-2201-1ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 301 in 1 CARTONLOTION13

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55560-220155560-2201-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
TETRADECANE03LY784Y58IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
ECTOINE7GXZ3858RYIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIHEPTYL SUCCINATE057N7SS26YIACT
COCO-GLUCOSIDEICS790225BIACT
XANTHAN GUMTTV12P4NEEIACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
SUNFLOWER OIL3W1JG795YIIACT
DOCOSANOL9G1OE216XYIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
LEVOMENOL24WE03BX2TIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
SODIUM GLUCONATER6Q3791S76IACT
GLYCERINPDC6A3C0OXIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TOCOPHEROLR0ZB2556P8IACT
.BETA.-SITOSTEROLS347WMO6M4IACT
SQUALENE7QWM220FJHIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ISOMALTS870P55O2WIACT
BEETN487KM8COKIACT
SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES8LLD82AE3SIACT
APPLEB423VGH5S9IACT
ARONIA MELANOCARPA FRUIT JUICED2EVP827PJIACT
TEA LEAFGH42T47V24IACT
ACAI46AM2VJ0AWIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
ARTHROSPIRA MAXIMA9K7IG15M0QIACT
PODOCORYNA CARNEA FIBRILLAR COLLAGENL2CJP3X029IACT
SOYBEAN LECITHIN1DI56QDM62IACT

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
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
ndc (package): 55560-2201-1
ndc (product): 55560-2201
ndc11 (package): 55560220101
spl id: 1a3506aa-6b67-4b83-be2f-bde467566fa0
spl set id: aa689e82-6512-46d8-aec9-269f9348d3f8

Reported adverse events (FAERS/openFDA)#

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