Pure & Simple Spray Spf 50

Pure & Simple Spray Spf 50
SPL v5
SPL
SPL Set ID b6492438-5dd2-030e-e053-2a95a90a2f9f
Route
TOPICAL
Published
Effective Date 2020-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (240.8 mg)
Inactive Ingredients
Propylene Glycol Cyclomethicone 5 Dimethicone Ethylhexyl Methoxycrylene Polyester-7 Isobutane Water Alkyl (c12-15) Benzoate Butyloctyl Salicylate Ethylhexyl Isononanoate Isopropyl Palmitate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Green Tea Leaf Macrocystis Pyrifera Synthetic Beeswax Caprylyl Trisiloxane Sodium Chloride Tocopherol 1,2-hexanediol Nelumbo Nucifera Leaf Triethoxycaprylylsilane Hydroxyacetophenone Peg-12 Dimethicone (300 Cst) Caprylyl Glycol Cetyl Dimethicone 150

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone ®Sunscreen Spray

Pure&Simple

100% Mineral Sun Protection

Free ofoxybenzone, octinoxate, PABA, parabens, dyes, fragrance

Hypoallergenic

Naturally sourced zinc oxide

With nourishing botanicals*

Water Resistanct (80 minutes)

Broad Specturm SPF 50

NET WT 5 OZ (142 g)

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

Drug Facts

Drug Facts

Questions?

1-866-288-3330

Active Ingredient

(To Deliver) 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 methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, caprylyl methicone, sodium chloride, cetyl dimethicone


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 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Coppertone ®Sunscreen Spray

Pure&Simple

100% Mineral Sun Protection

Free ofoxybenzone, octinoxate, PABA, parabens, dyes, fragrance

Hypoallergenic

Naturally sourced zinc oxide

With nourishing botanicals*

Water Resistanct (80 minutes)

Broad Specturm SPF 50

NET WT 5 OZ (142 g)

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

Drug Facts

Drug Facts

Questions?

1-866-288-3330

Active Ingredient

(To Deliver) 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 methoxycrylene, polyester-27, tea (camellia sinensis) leaf extract*, giant kelp (macrocystis pyrifera) extract*, sacred lotus (nelumbo nucifera) extract*, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, PEG-12 dimethicone crosspolymer, tocopherol, 1,2-hexanediol, caprylyl glycol, caprylyl methicone, sodium chloride, cetyl dimethicone


Advanced Ingredient Data


Raw Label Data

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