CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50 Lotion

Manufacturer
Caudalie USA, Inc.
Effective date
2024-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:49

Label at a glance#

ProductCAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure13 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 generously and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours • Use a 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, regulalry use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •Limit time ...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Active ingredient Purpose

Zinc Oxide 21.1% ...... 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

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply generously and evenly 15 minutes before sun exposure.

• Reapply at least every 2 hours • Use a 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, regulalry 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 singlasses.

•Children under 6 months of age: Ask a doctor.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Calcium Sodium Borosilicate, Erythritol, Lauryl Laurate, Propanediol, Carthamus Tinctorius Oleosomes, Bentonite, Niacinamide, Palmitoyl Grapevine Shoot Extract, Cetearyl Alcohol, Caprylyl Glycol, Ethyl Ferulate, Sucrose Polystearate, Helianthus Annuus (Sunflower) Seed Oil,Sucrose Stearate, Coco-Glucoside, Bisabolol, Citric Acid, Caramel, Polyhydroxystearic Acid, Pongamia Pinnata Seed Extract, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Tocopherol, Microcrystallnine Cellulose, Beta-Sitosterol, Gluconolactone, Squalene, Xanthan Gum, Aloe Barbadensis Leaf Juice Powder, Sodium Benzoate.

Questions?

OTC - QUESTIONS SECTION

+1-866-826-1615

30 mL Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 mL Outer Label_Page_130 mL Outer Label_Page_130 mL Outer Label_Page_230 mL Outer Label_Page_230 mL Inner Label30 mL Inner Label

50 mL Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 mL Outer Label50 mL Outer Label50 mL Inner Label50 mL Inner Label

Co-pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Copack Label_updatedCopack Label_updated

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76296-060-30CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 5037.5 g in 1 BOTTLELOTION37.52
76296-060-30CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION12
76296-060-39CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION12
76296-060-39CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 5037.5 g in 1 BOTTLELOTION37.52
76296-060-50CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 501 in 1 CARTONLOTION12
76296-060-50CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 5062.5 g in 1 BOTTLELOTION62.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76296-060CAUDALIE DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [CAUDALIE USA, INC.]2Current NDC, 6 package rows20241201_150e3bf3-7b05-e611-e063-6294a90a0932.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76296-06076296-060-30, 76296-060-50, 76296-060-39

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

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
CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDECaudalie USA, Inc.150e3bf3-7b05-e611-e063-6294a90a09322024-11-29WarningsExact identifier
ndc (package): 76296-060-39
ndc (package): 76296-060-30
ndc (package): 76296-060-50
ndc (product): 76296-060
ndc11 (package): 76296006030
ndc11 (package): 76296006050
ndc11 (package): 76296006039
spl id: 2812caa5-a889-fa8b-e063-6394a90a1f04
spl set id: 150e3bf3-7b05-e611-e063-6294a90a0932

Reported adverse events (FAERS/openFDA)#

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