p&s baby spray spf 50

p&s baby spray spf 50
SPL v3
SPL
SPL Set ID 088b7152-d3d1-9e74-e063-6394a90a4152
Route
topical
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (24.08 g)
Inactive Ingredients
isobutane ethylhexyl isononanoate water cetyl peg/ppg-10/1 dimethicone (hlb 2) caprylyl trisiloxane dimethicone caprylyl glycol alkyl (c12-15) benzoate butyloctyl salicylate propylene glycol peg-12 dimethicone ethylhexyl methoxycrylene cetyl dimethicone 150 hydroxyacetophenone isopropyl palmitate tocopherol cyclomethicone 5 triethoxycaprylylsilane synthetic beeswax 1,2-hexanediol polyester-7 bis-octyldodecyl dimer dilinoleate/propanediol copolymer ethylhexyl pelargonate sodium chloride

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2024-01-08

Purpose

Sunscreen

Description

Zinc Oxide (24.08%)


Medication Information

Warnings

For external use only

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

Uses

■ helps prevent sunburn

Purpose

Sunscreen

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

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

Description

Zinc Oxide (24.08%)

Questions?

1-866-288-3330

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 Recommended Sunscreen Spray

Baby

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free

Suitable for Sensitive Skin

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

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Active Ingredient

Zinc Oxide (24.08%)


Structured Label Content

Warnings

For external use only

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

Uses

■ helps prevent sunburn

Purpose

Sunscreen

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

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

Questions?

1-866-288-3330

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 Recommended Sunscreen Spray

Baby

50

100% Mineral Sun Protection

Hypoallergenic & Tear Free

Suitable for Sensitive Skin

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

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Active Ingredient (Active ingredient)

Zinc Oxide (24.08%)


Advanced Ingredient Data


Raw Label Data

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