FDA.reportPublic FDA data

STATE-48 SUNCARE MINERAL SPF-30

Manufacturer
State 48 Suncare LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:50

Label at a glance#

ProductSTATE-48 SUNCARE MINERAL SPF-30
Active ingredientZINC OXIDE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

Dosage and administration

Apply liberally 15 minutes before sun exposure. Children under 6 months of age:ask a doctor Reapply at least every 2 hours. Reapply as needed or after towel drying swimming or sweating. Use a ater-resistant sunscreen if swimming or sweating. 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 hig...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 6.00%

Octisalate 5.00%,

Octocrylene 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

Warnings:

WARNINGS SECTION

For externel use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove. 

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age:ask a doctor
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying swimming or sweating.
  • Use a ater-resistant sunscreen if swimming or sweating.
  • 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:  Sun Protection Measures.
  • Limit time in the sun, especially from 10a.m. - 2.p.m. 
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Bixa Orellana (Annatto) Extract, Butylcotyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Chamomilla Recutita (Chamomile) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower)Oil, Hydroxyethylcellulose, Leuconostoc/Radih Root Ferment Filtrate, Mangifera Indica (Mango) Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Other Information

SPL UNCLASSIFIED SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 877-266-8157

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81200-10981200-109-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARGAN OIL4V59G5UW9XIACT
BIXA ORELLANA SEEDO87354RZ5AIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CHAMOMILEFGL3685T2XIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
ETHYL VANILLINYC9ST449YJIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
MANGOI629I3NR86IACT
AVOCADO OIL6VNO72PFC1IACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
ZINC OXIDESOI2LOH54ZACTIM
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
29215c7b-db41-db8d-e063-6394a90a460b05ae9904-3b7f-4cec-9035-deb230cfee302024-12-13WarningsExact identifier
spl id: 29215c7b-db41-db8d-e063-6394a90a460b
spl set id: 05ae9904-3b7f-4cec-9035-deb230cfee30

Reported adverse events (FAERS/openFDA)#

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