Caring Mill Kid’s Sunscreen Spray Spf 50

Caring Mill Kid’s Sunscreen Spray Spf 50
SPL v1
SPL
SPL Set ID 0ec21837-d4f1-0916-e063-6294a90a2199
Route
TOPICAL
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Butylene Glycol Dicaprylate/dicaprate Ascorbyl Palmitate Alcohol Neopentyl Glycol Diheptanoate Alkyl (c12-15) Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-20

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5%

Uses
  • helps prevent sunburn
Warnings

For external use only

Flammable:Do not use near heat, flame, or while smoking

Directions
  • Shake well before each use
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Hold container 4 to 6 inches from the skin to apply 
  • Do not spray directly into face. Spray on hands then apply to face. 
  • Do not apply in windy conditions 
  • Use in a well-ventilated area
  • Reapply 
  • After 80 minutes of swimming or sweating
  • Immediateky after towel drying 
  • At least every 2 hours 
  • 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-sleeve shirts, pants, hats, and sunglasses 
  • Children under 6 months: Ask a doctor
Drug Facts

Do Not Use On

damaged or broken skin

Other Information

Protect this product from excessive heat and direct sun. Store between 68°F to 77°F (20°C to 25°C). May stain or damage some fabrics or surfaces.

Package Labeling:

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Inactive Ingredients

Alcohol(45%), Neopentyl Glycol Diheptanoate, C12-C15 Alkyl Benzoate, Butylene Glycol Dicaprylate/Dicaprate, Acrylates/Octylacrylamide Copolymer, Fragrance, Ascorbyl Palmitate

When Using This Product
  • keep away from face to avoid breathing it
  • keep out of eyes. Rinse with water to remove.
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • Do not store at temperatures above 120°F
Stop Use and Ask A Doctor If

rash occurs

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

Flammable:Do not use near heat, flame, or while smoking

Directions
  • Shake well before each use
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure 
  • Hold container 4 to 6 inches from the skin to apply 
  • Do not spray directly into face. Spray on hands then apply to face. 
  • Do not apply in windy conditions 
  • Use in a well-ventilated area
  • Reapply 
  • After 80 minutes of swimming or sweating
  • Immediateky after towel drying 
  • At least every 2 hours 
  • 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-sleeve shirts, pants, hats, and sunglasses 
  • Children under 6 months: Ask a doctor
Drug Facts

Do Not Use On (Do not use on)

damaged or broken skin

Other Information (Other information)

Protect this product from excessive heat and direct sun. Store between 68°F to 77°F (20°C to 25°C). May stain or damage some fabrics or surfaces.

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Inactive Ingredients (Inactive ingredients)

Alcohol(45%), Neopentyl Glycol Diheptanoate, C12-C15 Alkyl Benzoate, Butylene Glycol Dicaprylate/Dicaprate, Acrylates/Octylacrylamide Copolymer, Fragrance, Ascorbyl Palmitate

When Using This Product (when using this product)
  • keep away from face to avoid breathing it
  • keep out of eyes. Rinse with water to remove.
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • Do not store at temperatures above 120°F
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 product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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