NATURAL MINERAL SUNSCREEN- titanium dioxide, zinc oxide lotion

Natural Mineral Sunscreen by

Drug Labeling and Warnings

Natural Mineral Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sarati International, Inc., Sarati International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients:

Titanium Dioxide 4.7%

Zinc Oxide 9.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

Warnings:

• For external use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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

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.

DO NOT USE

Do not use

• on danaged or broken skin

WHEN USING

When using this product,

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

STOP USE

Stop use and ask a doctor

• if rash occurs.

PRINCIPAL DISPLAY PANEL

STELLAR

SUNSCREEN

Broad Spectrum SPF 30

Water Resistant

(40 minutes)

30

Net Wt. 3.4 fl. oz.

INGREDIENTS AND APPEARANCE

NATURAL MINERAL SUNSCREEN 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67676-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.95 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
WATER (UNII: 059QF0KO0R)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERULIC ACID (UNII: AVM951ZWST)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGENATED ETHYLHEXYL OLIVATE (UNII: JBH5K4WD8L)
HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)
ISOHEXADECANE (UNII: 918X1OUF1E)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67676-009-01	100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/16/2024

Labeler - Sarati International, Inc. (160219770)

Registrant - Sarati International, Inc (160219770)

Establishment
Name	Address	ID/FEI	Business Operations
Sarati International, Inc.		160219770	manufacture(67676-009)