Topco Topcare Everyday Baby Protection Sun Lotion Spf 50

Topco Topcare Everyday Baby Protection Sun Lotion Spf 50
SPL v2
SPL
SPL Set ID f71c9060-3daf-e1be-e053-6294a90a4f91
Route
TOPICAL
Published
Effective Date 2018-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (145 mg) Octisalate (50 mg)
Inactive Ingredients
Water Neopentyl Glycol Diheptanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Propylene Glycol Aloe Vera Leaf Sodium Chloride Cyclomethicone 4 Alkyl (c12-15) Benzoate Cyclomethicone 5 Benzyl Alcohol Benzoic Acid Sorbic Acid Triethoxycaprylylsilane Tridecyl Salicylate Ethylhexyl Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-02

Description

Octisalate 5.0%, Zinc Oxide 14.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octisalate 5.0%, Zinc Oxide 14.5%

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 casued by the sun
Label

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure

  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor

  • 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

Do Not Use

• on damaged or broken skin

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Octisalate 5.0%, Zinc Oxide 14.5%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Propylene Glycol, Tridecyl Salicylate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Caprylyl Glycol, Phexoethanol, Hexylene Glycol, Sodium Chloride.

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• rash occurs

Keep Out of Reach of Children.

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


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 casued by the sun
Label

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure

  • reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

  • children under 6 months of age: Ask a doctor

  • 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

Do Not Use (Do not use)

• on damaged or broken skin

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Octisalate 5.0%, Zinc Oxide 14.5%

Inactive Ingredients (Inactive ingredients)

Water, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Propylene Glycol, Tridecyl Salicylate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Caprylyl Glycol, Phexoethanol, Hexylene Glycol, Sodium Chloride.

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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