Spf 50 Uva-uvb Tinted Sunscreen

Spf 50 Uva-uvb Tinted Sunscreen
SPL v1
SPL
SPL Set ID 468c90d7-3b9e-1641-e063-6394a90a928c
Route
TOPICAL
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (8.4 g) Titanium Dioxide (11.2 g)
Inactive Ingredients
Apricot Kernel Oil Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Trihydroxystearin Alumina Ferrosoferric Oxide Stearic Acid Hexyl Laurate Ferric Oxide Red Ethylene Brassylate Oryza Sativa (rice) Bran Solanum Lycopersicum Fruiting Top Lupinus Albus Seed Oil Alpha-tocopherol Acetate Copernicia Cerifera (carnauba) Wax Ferric Oxide Yellow Triticum Vulgare (wheat) Germ Oil Unsaponifiables Triethoxycaprylylsilane Tocopherol Peg-10 Dimethicone (220 Cst) Polyglyceryl-4 Isostearate Polymethylsilsesquioxane (4.5 Microns) Isononyl Isononanoate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-01

Description

Product Facts / Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Product Facts / Drug Facts

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.

Section 42229-5

Product Facts / Drug Facts

Section 50565-1

Keep out of reach of children.

If 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 damaged or broken skin.

Section 51945-4

Warnings

For external use only.

Directions

Adults over 18 years old:

• apply liberally 15 minutes before sun exposure.

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease 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.

Questions?

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

Active Ingredients

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Other Informations

• protect this product from excessive heat and direct sun.

• keep at room temperature (15 - 30˚C / 59 - 86˚F)

Inactive Ingredients



LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE COPERNICIA CERIFERA (CARNAUBA), POLYSILICONE-11, ISONONYL ISONONANOATE, TRIHYDROXYSTEARIN, POLYGLYCERYL- 4 ISOSTEARATE, POLYMETHYLSILSESQUIOXANE, STEARIC ACID / ACIDE STÉARIQUE, IRON OXIDES / OXYDES DE FER, PRUNUS ARMENIACA (APRICOT) KERNEL OIL / HUILE DE PRUNUS ARMENIACA (ABRICOT), TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPINUS ALBUS, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / INSAPONIFIABLES D’HUILE DE GERMES DE TRITICUM VULGARE (BLÉ), SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/ TIGE/FEUILLE DE SOLANUM LYCOPERSICUM (TOMATE), TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON D’ORYZA SATIVA (RIZ), TRIETHOXYCAPRYLYLSILANE.


Structured Label Content

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.

Section 42229-5 (42229-5)

Product Facts / Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If 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 damaged or broken skin.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only.

Directions

Adults over 18 years old:

• apply liberally 15 minutes before sun exposure.

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease 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.

Questions?

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

Active Ingredients (Active ingredients)

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Other Informations (Other informations)

• protect this product from excessive heat and direct sun.

• keep at room temperature (15 - 30˚C / 59 - 86˚F)

Inactive Ingredients (Inactive ingredients)



LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE COPERNICIA CERIFERA (CARNAUBA), POLYSILICONE-11, ISONONYL ISONONANOATE, TRIHYDROXYSTEARIN, POLYGLYCERYL- 4 ISOSTEARATE, POLYMETHYLSILSESQUIOXANE, STEARIC ACID / ACIDE STÉARIQUE, IRON OXIDES / OXYDES DE FER, PRUNUS ARMENIACA (APRICOT) KERNEL OIL / HUILE DE PRUNUS ARMENIACA (ABRICOT), TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPINUS ALBUS, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / INSAPONIFIABLES D’HUILE DE GERMES DE TRITICUM VULGARE (BLÉ), SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/ TIGE/FEUILLE DE SOLANUM LYCOPERSICUM (TOMATE), TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON D’ORYZA SATIVA (RIZ), TRIETHOXYCAPRYLYLSILANE.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)