FDA.reportPublic FDA data

SPF 30 Mineral Sunscreen Lotion

Manufacturer
Salt and Stone LLC
Effective date
2019-09-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:29

Label at a glance#

ProductSPF 30 Mineral Sunscreen
Active ingredientZINC OXIDE
Label structure7 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: After 80 minutes of swimming or sweating Immediately after towel drying At least every 2 hours 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 22.7%

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

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 

OTC - STOP USE SECTION

ir rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 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 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 10am-2 2pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Protect this product from excess heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Coco-caprylate, Polyglyceryl-3 polyricinoleate, Isostearic acid, Purified water, medium chain triglycerides, Octyl palmitate, Dimethicone, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Glycerol, Beeswax, Polyethylene, Gluconolactone, Sodium benzoate, Calcium gluconate, Glyceryl Monooleate, Avocado oil, Fragrace, Rosa canina (rose hip) oil, Hyaluronic acid, Xanthan gum.
Organic Ingredient

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New Label2New Label2

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71585-13571585-135-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCO-CAPRYLATE4828G836N6IACT
ISOSTEARIC ACIDX33R8U0062IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYL PALMITATE2865993309IACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
GLYCERINPDC6A3C0OXIACT
YELLOW WAX2ZA36H0S2VIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
CALCIUM GLUCONATESQE6VB453KIACT
GLYCERYL MONOOLEATEC4YAD5F5G6IACT
AVOCADO OIL6VNO72PFC1IACT
HYALURONIC ACIDS270N0TRQYIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
b6356163-2f15-7fb0-e053-2995a90a23cf9484b2b6-d8b3-4e33-8752-e3498ff85c002020-12-11WarningsExact identifier
spl set id: 9484b2b6-d8b3-4e33-8752-e3498ff85c00

Reported adverse events (FAERS/openFDA)#

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