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

Purpose

Sunscreen

Description

Octisalate 5.0%, Zinc Oxide 14.5%


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 casued by the sun
Purpose

Sunscreen

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

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

Description

Octisalate 5.0%, Zinc Oxide 14.5%

Label

Do Not Use

• on damaged or broken skin

Active Ingredients

Octisalate 5.0%, Zinc Oxide 14.5%

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

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 casued by the sun
Purpose

Sunscreen

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

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
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.

Label

Do Not Use (Do not use)

• on damaged or broken skin

Active Ingredients (Active ingredients)

Octisalate 5.0%, Zinc Oxide 14.5%

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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