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
Purpose

Sunscreen

Description

Product Facts / Drug Facts

Medication Information

Warnings

For external use only.

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.

Purpose

Sunscreen

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.

Other Information

• protect this product from excessive heat and direct sun.

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

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.

Description

Product Facts / Drug Facts

Questions?

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

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

Active Ingredient:

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Structured Label Content

Warnings

For external use only.

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.

Purpose

Sunscreen

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.

Other Information (Other information)

• protect this product from excessive heat and direct sun.

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

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.

Questions?

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

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)

Active Ingredient: (Active ingredient:)

Titanium Dioxide 11.2%

Zinc Oxide 8.4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:31.643932 · Updated: 2026-03-14T23:11:05.615438