16ef922d-78d1-1e70-e063-6394a90a3bbf

SPL v1
SPL
SPL Set ID 16ef922d-78d1-1e70-e063-6394a90a3bbf
Route
topical
Published
Effective Date 2024-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (4.95 g) zinc oxide (9.5 g)
Inactive Ingredients
aluminum oxide behentrimonium methosulfate alkyl (c12-15) benzoate medium-chain triglycerides cetostearyl alcohol arabica coffee bean water diisostearoyl polyglyceryl-3 dimer dilinoleate propylene carbonate triethoxycaprylylsilane edetic acid disteardimonium hectorite ethylhexylglycerin ferulic acid glycerin sodium chloride 4-(p-hydroxyphenyl)-2-butanone stearic acid hydrogenated ethylhexyl olivate hydrogenated olive oil unsaponifiables isohexadecane niacinamide peg-30 dipolyhydroxystearate phenoxyethanol polyhydroxystearic acid (2300 mw) propanediol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-16
Description

Active Ingredients: Titanium Dioxide 4.7% Zinc Oxide 9.5%

Medication Information

Warnings and Precautions

Warnings:

  • For external use only
Indications and 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
Dosage and 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.
Description

Active Ingredients: Titanium Dioxide 4.7% Zinc Oxide 9.5%

Section 43683-2

Updated directions as required for Broad Spectrum and Water Resistant Testing

Updated label and principal display panel.

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor

  • if rash occurs.
Section 50567-7

When using this product,

  • keep out of eyes. Rinse with water to remove.
Section 50570-1

Do not use

  • on danaged or broken skin
Section 51727-6

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

Section 51945-4

STELLAR

SUNSCREEN

Broad Spectrum SPF 30

Water Resistant

(40 minutes)

30

Net Wt. 3.4 fl. oz.

Section 55105-1

Purpose

Sunscreen

Section 60561-8

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

Active Ingredients

Active Ingredients:

Titanium Dioxide 4.7%

Zinc Oxide 9.5%

Structured Label Content

Warnings and Precautions (34071-1)

Warnings:

  • For external use only
Indications and Usage (34067-9)

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 (34068-7)

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.
Section 43683-2 (43683-2)

Updated directions as required for Broad Spectrum and Water Resistant Testing

Updated label and principal display panel.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • if rash occurs.
Section 50567-7 (50567-7)

When using this product,

  • keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)

Do not use

  • on danaged or broken skin
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

STELLAR

SUNSCREEN

Broad Spectrum SPF 30

Water Resistant

(40 minutes)

30

Net Wt. 3.4 fl. oz.

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 60561-8 (60561-8)

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

Active Ingredients

Active Ingredients:

Titanium Dioxide 4.7%

Zinc Oxide 9.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:34.629711 · Updated: 2026-03-14T23:03:44.598062