FDA.reportPublic FDA data

Natural Mineral Sunscreen

Manufacturer
Sarati International, Inc. | Sarati International, Inc
Effective date
2024-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:35

Label at a glance#

ProductNatural Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Titanium Dioxide 4.7%

Zinc Oxide 9.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

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

Warnings:

  • For external use only

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

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply liberally and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun.
  • Reapply
  • after 40 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 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENT SECTION

Alumina, Behentrimonium Methosulfate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Coffea Arabica (Coffee) Fruit Extract, Deionized Water, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Ferulic Acid, Glycerin, Hydrogenated Ethylhexyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Isohexdecane, Niacinamide, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Raspberry Ketone, Sodium Chloride, Stearic Acid, Triethoxycaprylylsilane

OTHER SAFETY INFORMATION

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

RECENT MAJOR CHANGES SECTION

Updated directions as required for Broad Spectrum and Water Resistant Testing

Updated label and principal display panel.

OTC - DO NOT USE SECTION

Do not use

  • on danaged 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF 30SPF 30STELLAR

SUNSCREEN

Broad Spectrum SPF 30

Water Resistant

(40 minutes)

30

Net Wt. 3.4 fl. oz.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67676-009-01Natural Mineral Sunscreen100 g in 1 BOTTLE, PUMPLOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67676-009NATURAL MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SARATI INTERNATIONAL, INC.]1Current NDC, 1 package rows20240917_16ef922d-78d1-1e70-e063-6394a90a3bbf.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67676-00967676-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUM OXIDELMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARABICA COFFEE BEAN3SW678MX72IACT
WATER059QF0KO0RIACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEG3232Z5S2OIACT
PROPYLENE CARBONATE8D08K3S51EIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
EDETATE DISODIUM7FLD91C86KIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERULIC ACIDAVM951ZWSTIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
4-(P-HYDROXYPHENYL)-2-BUTANONE7QY1MH15BGIACT
STEARIC ACID4ELV7Z65APIACT
HYDROGENATED ETHYLHEXYL OLIVATEJBH5K4WD8LIACT
HYDROGENATED OLIVE OIL UNSAPONIFIABLESB8MIX97W95IACT
ISOHEXADECANE918X1OUF1EIACT
ZINC OXIDESOI2LOH54ZACTIB
NIACINAMIDE25X51I8RD4IACT
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT

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
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
ndc (package): 67676-009-01
ndc (product): 67676-009
ndc11 (package): 67676000901
spl id: 16ef922d-78d2-1e70-e063-6394a90a3bbf
spl set id: 16ef922d-78d1-1e70-e063-6394a90a3bbf

Reported adverse events (FAERS/openFDA)#

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