P&s Kids Spray

P&s Kids Spray
SPL v3
SPL
SPL Set ID 09a97e3f-f6dc-eaa7-e063-6294a90ad274
Route
TOPICAL
Published
Effective Date 2023-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.08 g)
Inactive Ingredients
Dimethicone Synthetic Beeswax Tocopherol Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Caprylyl Trisiloxane Isobutane Butyloctyl Salicylate Propylene Glycol Peg-12 Dimethicone Isopropyl Palmitate Ethylhexyl Pelargonate Water Alkyl (c12-15) Benzoate Ethylhexyl Methoxycrylene Caprylyl Glycol Cyclomethicone 5 Polyester-7 Cetyl Dimethicone 150 Ethylhexyl Isononanoate Triethoxycaprylylsilane Hydroxyacetophenone Sodium Chloride 1,2-hexanediol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-08

Description

Zinc Oxide (24.08%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide (24.08%)

Use

■ helps prevent sunburn

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 ifrash occurs

Section 50567-7

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 puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone

Zinc Oxide Sunscreen Spray

Pure & Simple

#1 Pediatrician Recommendd Sunscreen Brand

Kids

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free

Suitable for Sensitive Skin

Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragrance

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

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

■ immediately 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

Questions?

1-866-288-3330

Active Ingredient

Zinc Oxide (24.08%)

Other Information

■ protect this product from excessive heat and direct sun

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive Ingredients

isobutane, water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, cetyl dimethicone, triethoxycaprylylsilane, beeswax, tocopherol (vitamin E), hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, caprylyl methicone


Structured Label Content

Use

■ helps prevent sunburn

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 ifrash occurs

Section 50567-7 (50567-7)

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 puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Coppertone

Zinc Oxide Sunscreen Spray

Pure & Simple

#1 Pediatrician Recommendd Sunscreen Brand

Kids

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free

Suitable for Sensitive Skin

Free of Oxybenzone, Octinoxate, PABA, Parabens, Dyes, Fragrance

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

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

■ immediately 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

Questions?

1-866-288-3330

Active Ingredient (Active ingredient)

Zinc Oxide (24.08%)

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

isobutane, water, C12-15 alkyl benzoate, isopropyl palmitate, butyloctyl salicylate, ethylhexyl isononanoate, cetyl PEG/PPG-10/1 dimethicone, propylene glycol, cyclopentasiloxane, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, dimethicone, ethylhexyl pelargonate, ethylhexyl methoxycrylene, polyester-27, cetyl dimethicone, triethoxycaprylylsilane, beeswax, tocopherol (vitamin E), hydroxyacetophenone, sodium chloride, PEG-12 dimethicone crosspolymer, 1,2-hexanediol, caprylyl glycol, caprylyl methicone


Advanced Ingredient Data


Raw Label Data

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