FDA.reportPublic FDA data

Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30

Manufacturer
Andalou naturals | Sun Deep Inc
Effective date
2019-07-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:38:27

Label at a glance#

ProductArgan Stem Cell BB Benefit Balm Un-Tinted SFP 30
Active ingredientZINC OXIDE
Label structure11 sections

Indications and uses

Helps prevent sunburn.

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. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To ...

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 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

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.
  • 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.

Non Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice1, Purified Water (Aqua), Caprylic/Capric Triglycerides, Vegetable Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil1, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil1, Punica Granatum (Pomegranate) Seed Oil1, Hydrogenated Castor Oil, Dimethicone, Magnesium Sulfate, Sorbitan Sesquioleate, Fruit Stem Cells (Argan, Malus Domestica, Solar Vitis) and BioActive Berry Complex1, Sodium Hyaluronate, Salix Alba (Willow Bark) Extract1, Serenoa Rapens (Saw Palmetto) Fruit Extract1, Magnesium Ascorbyl Phosphate (Vitamin C), Borago Officinalis (Borage) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Zea Mays (Corn) Starch1, Camellia Sinensis (White Tea) Leaf Extract1 2, Hibiscus Sabdariffa Flower Extract1 2, Tocopherol, Phenethyl Alcohol, Ethylhexylglycerin, Citrus Aurantium Dulcis (Orange) Peel Oil1, Cymbopogon Martini (Palmarosa) Leaf Oil1

1 Certified Organic/Organic

2 Fair Trade/Biologique

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
Novato, CA 94945 USA

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMPROVED!

ANDALOU
NATURALS

NON
GMO

BB

Argan Stem Cell
BENEFIT BALM

Un-Tinted
SPF 30

with Argan Stem Cells
Energized Renewal

Broad Spectrum Protection

FRUIT
STEM
CELL

SCIENCE®

CLEAR SKIN

NPN 80042784

2 fl oz e 58 mL

Principal Display Panel - 58 mL Tube Carton
Principal Display Panel - 58 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55560-0109-12025-01-30C16284748780-1ba0f9c33-5af3-a910-e053-dadaa90a0b85Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30
55560-0109-12023-02-02C16284748780-1ba0f9c33-5af3-a910-e053-dadaa90a0b85Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30
55560-0109-12021-01-29C16284748780-1ba0f9c33-5af3-a910-e053-dadaa90a0b85Argan Stem Cell BB Benefit Balm Un-Tinted SFP 30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55560-0109ARGAN STEM CELL BB BENEFIT BALM UN-TINTED SFP 30 (ZINC OXIDE) LOTION [ANDALOU NATURALS]5Legacy NDC20230203_b1636ea7-b4a6-49db-97cc-064d1ad4d423.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55560-010955560-0109-1

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
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
JOJOBA OIL724GKU717MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
SUNFLOWER OIL3W1JG795YIIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
DIMETHICONE92RU3N3Y1OIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
APPLEB423VGH5S9IACT
VITIS VINIFERA SEEDC34U15ICXAIACT
ACAI46AM2VJ0AWIACT
ARONIA MELANOCARPA FRUIT JUICED2EVP827PJIACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
VACCINIUM MYRTILLUS ANTHOCYANOSIDESR911H793SUIACT
EUROPEAN ELDERBERRY JUICEZ4IFJ0AK1EIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
ROSA CANINA FRUIT3TNW8D08V3IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WILLOW BARKS883J9JDYXIACT
SAW PALMETTOJ7WWH9M8QSIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
BORAGE SEED OILF8XAG1755SIACT
CUCUMBERYY7C30VXJTIACT
STARCH, CORNO8232NY3SJIACT
WHITE TEAO0M3396E09IACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
TOCOPHEROLR0ZB2556P8IACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
PALMAROSA OIL0J3G3O53STIACT

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
f538fff3-a397-4cab-a407-7afcbdc51d97b1636ea7-b4a6-49db-97cc-064d1ad4d4232026-03-12WarningsExact identifier
spl set id: b1636ea7-b4a6-49db-97cc-064d1ad4d423

Reported adverse events (FAERS/openFDA)#

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