Gm Collin Spf45 Tinted Sunscreen

Gm Collin Spf45 Tinted Sunscreen
SPL v3
SPL
SPL Set ID 01dcfd14-7a1d-98fa-e063-6294a90a0336
Route
TOPICAL
Published
Effective Date 2024-01-01
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
Aluminum Oxide Ethylene Brassylate Solanum Lycopersicum Fruiting Top Alpha-tocopherol Acetate Rice Bran Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide Apricot Kernel Oil Lupinus Albus Seed Oil Triethoxycaprylylsilane Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Wheat Germ Oil Unsaponifiables Trihydroxystearin Hexyl Laurate Carnauba Wax Peg-10 Dimethicone (220 Cst) Polymethylsilsesquioxane (4.5 Microns) Stearic Acid Isononyl Isononanoate Polyglyceryl-4 Isostearate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

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

Other Information

• protect this product from excessive heat and direct sun.

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

Active Ingredient:

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Inactive Ingredients

DIMETHICONE, PEG-10 DIMETHICONE, HEXYL LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE 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 NOYAU D’ABRICOT, TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPIN, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / HUILES INSAPONIFIABLES DE GERME BLÉ, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/FEUILLE/TIGE DE TOMATE, TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON DE 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

Other Information (Other information)

• protect this product from excessive heat and direct sun.

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

Active Ingredient: (Active ingredient:)

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Inactive Ingredients (Inactive ingredients)

DIMETHICONE, PEG-10 DIMETHICONE, HEXYL LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE 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 NOYAU D’ABRICOT, TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPIN, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / HUILES INSAPONIFIABLES DE GERME BLÉ, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/FEUILLE/TIGE DE TOMATE, TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON DE RIZ, TRIETHOXYCAPRYLYLSILANE.


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Raw Label Data

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