​sunsorb

​sunsorb
SPL v7
SPL
SPL Set ID b4fc7a51-a163-4057-8790-f2111668ec67
Route
TOPICAL
Published
Effective Date 2024-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Zinc Cation (57 mg) Octocrylene (50 mg)
Inactive Ingredients
Water Aloe Vera Leaf Hydrogenated Polybutene (1300 Mw) Polyglyceryl-4 Isostearate Cyclomethicone Octyl Stearate Isopropyl Palmitate Sunflower Oil Cetostearyl Alcohol Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Cetyl Dimethicone 150 Hydrogenated Castor Oil Sodium Chloride Polyglyceryl-3 Oleate Silicon Dioxide Hexyl Laurate Triethoxycaprylylsilane Caprylyl Glycol Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15

Description

Homosalate 10.0% w/w Zinc Oxide   5.7% w/w Octocrylene 5.0% w/w

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.0% w/w Zinc Oxide   5.7% w/w Octocrylene 5.0% w/w

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 or irritation develops and lasts

Section 50568-5

- ​Children under 6 months:​ Ask a doctor

Section 51945-4

​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

​warnings

​For external use only

Do not useon damaged or broken skin

​When using this product

- Keep out of eyes.  Rinse with water to remove.

​directions

- Apply liberally 15 minutes before sun exposure

- Reapply

  - After 80 minutes of swimming or sweating

  - Immediately after towel drying

  - At least every 2 hrs

- ​Sun Protection Measures​.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other skin protection measures including:

  - limit time in the sun, especially from 10 a.m. - 2 p.m.

  - wear long-sleeve shirts, pants, hats, and sunglasses

​other Information

- Protect this product from excessive heat and direct sun.

​inactive Ingredients:

Water, Aloe Barbadensis Leaf Extract, Hydrogenated Polybutene, Polyglyceryl-4-Isostearate, Cyclomethicone, Octyl Stearate, Isopropyl Palmitate, Sunflower Oil, Emulsifying Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3 Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Caprylyl Glycol, Methylisothiazolinone.

​ ​active Ingredients

Homosalate 10.0% w/w

Zinc Oxide   5.7% w/w

Octocrylene 5.0% w/w

​questions Or Comments?

1-800-445-2563


Structured Label Content

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 or irritation develops and lasts

Section 50568-5 (50568-5)

- ​Children under 6 months:​ Ask a doctor

Section 51945-4 (51945-4)

​uses (​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 (​Purpose)

Sunscreen

​warnings (​Warnings)

​For external use only

Do not useon damaged or broken skin

​When using this product

- Keep out of eyes.  Rinse with water to remove.

​directions (​Directions)

- Apply liberally 15 minutes before sun exposure

- Reapply

  - After 80 minutes of swimming or sweating

  - Immediately after towel drying

  - At least every 2 hrs

- ​Sun Protection Measures​.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other skin protection measures including:

  - limit time in the sun, especially from 10 a.m. - 2 p.m.

  - wear long-sleeve shirts, pants, hats, and sunglasses

​other Information (​Other Information)

- Protect this product from excessive heat and direct sun.

​inactive Ingredients: (​Inactive Ingredients:)

Water, Aloe Barbadensis Leaf Extract, Hydrogenated Polybutene, Polyglyceryl-4-Isostearate, Cyclomethicone, Octyl Stearate, Isopropyl Palmitate, Sunflower Oil, Emulsifying Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3 Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Caprylyl Glycol, Methylisothiazolinone.

​ ​active Ingredients (​ ​Active Ingredients)

Homosalate 10.0% w/w

Zinc Oxide   5.7% w/w

Octocrylene 5.0% w/w

​questions Or Comments? (​Questions or Comments?)

1-800-445-2563


Advanced Ingredient Data


Raw Label Data

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