P&s Spray Spf 50

P&s Spray Spf 50
SPL v3
SPL
SPL Set ID 0806bdb9-961f-3146-e063-6294a90a4625
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
1,2-hexanediol Dimethicone Caprylyl Trimethicone Ethylhexyl Isononanoate Synthetic Beeswax Caprylyl Glycol Alkyl (c12-15) Benzoate Isobutane Water Sodium Chloride Isopropyl Palmitate Dipropylene Glycol Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Polyester-7 Ethylhexyl Methoxycrylene Butyloctyl Salicylate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Cyclomethicone 5 Ethylhexyl Pelargonate Cetyl Dimethicone 150 Hydroxyacetophenone Peg-12 Dimethicone Tocopherol Triethoxycaprylylsilane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-03

Description

Zinc Oxide 24.08%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24.08%

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 caused by the sun

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 51945-4

Coppertone

Zinc Oxide Snscreen Spray

Pure&Simple

50

100% Mineral Sun Protection

Hypoallergenic

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

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 caused by the sun

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 51945-4 (51945-4)

Coppertone

Zinc Oxide Snscreen Spray

Pure&Simple

50

100% Mineral Sun Protection

Hypoallergenic

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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