FDA.reportPublic FDA data

YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen

Manufacturer
CA-Botana International
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:57

Label at a glance#

ProductYOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

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

Directions Apply liberally and evenly 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours. Sun Protection Measures. Spending time int he 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 incl...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

OTC - PURPOSE SECTION

Active IngredientPurpose
Zinc Oxide 21%Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours.
  • Sun Protection Measures. Spending time int he 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.
  • children under 6 months of age: ask a doctor

OTHER SAFETY INFORMATION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water/Aqua/Eau, Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Glyceryl Stearate, Cetearyl Olivate, Carthamus Tinctorious (Safflower) Seed Oil, Sorbitan Olivate, Caprylhydrozamic Acid, Xanthan Gum, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (Rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Glyceryl Caprylate, Glycerin, Aesculus Hippocastanum (Horse Chestnut) Extract, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Extract, Tocopheryl Acetate, Potassium Sorbate, Sodium Phytate, Silica, Triethoxycaprylsilane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Citric Acid, Iron Oxides (CI 77491).

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments? clearstem.com

YOUARE SUNSHINE Broad Spectrum SPF 50+ - 65 g - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEARSTEM
CLEAR PORE PROMISE

YOU ARE

SUNSHINE

Broad Spectrum SPF 50+

Mineral Sunscreen

No Pore-Clogging

Ingredients, Ever

WATER RESISTANT

(80 MINUTES)

ZINC OXIDE 21%

65 g 2.2 oz

YASYAS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35192-100-00YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen65 g in 1 BOTTLE, PUMPLOTION651
35192-100-00YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral Sunscreen1 in 1 CARTONLOTION11

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-10035192-100-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
OLEA EUROPAEA WHOLE769297N5OKIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
TOCOPHEROLR0ZB2556P8IACT
ASCORBYL PALMITATEQN83US2B0NIACT
CITRIC ACID2968PHW8QPIACT
CI 774911K09F3G675IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
ROSMARINUS OFFICINALIS WHOLEEA3289138MIACT
ZINC OXIDESOI2LOH54ZACTIB
SORBITAN OLIVATEMDL271E3GRIACT
CENTELLA ASIATICA7M867G6T1UIACT
GLYCERINPDC6A3C0OXIACT
STEARYL ALCOHOL2KR89I4H1YIACT
EQUISETUM ARVENSE WHOLE73DM367W4PIACT
SODIUM PHYTATE88496G1ERLIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL65UEH262ISIACT
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDERIJ67X351P9IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CETEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE230OU9XXE4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AESCULUS HIPPOCASTANUM WHOLE2331W47PSXIACT
PROPANEDIOL5965N8W85TIACT
CETEARYL OLIVATE58B69Q84JOIACT

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
YOUARE SUNSHINE Broad Spectrum SPF 50 Mineral SunscreenZINC OXIDECA-Botana International4d74a36c-ff68-afd9-e063-6394a90a08f82026-03-20WarningsExact identifier
ndc (package): 35192-100-00
ndc (product): 35192-100
ndc11 (package): 35192010000
spl id: 4d74a36c-ff69-afd9-e063-6394a90a08f8
spl set id: 4d74a36c-ff68-afd9-e063-6394a90a08f8

Reported adverse events (FAERS/openFDA)#

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