Pure & Simple Lotion Spf 50

Pure & Simple Lotion Spf 50
SPL v8
SPL
SPL Set ID d8d80a15-8282-a18e-e053-2a95a90a2c6c
Route
TOPICAL
Published
Effective Date 2022-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-03

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 productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone ®Sunscreen Lotion

Pure & Simple

100% Mineral Sun Protection

50

Free Of oxybenzone, octinoxate, PABA, parabens, dyes, fragrance

  • Hypoallergenic
  • Naturally sourced zinc oxide
  • With nourishing botanicals*

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Warnings

For external use only

Directions

■ shake well before each use

■ apply liberally 15 minutes before sun exposure

■ 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

Other Information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients

Zinc Oxide 24.08%

Inactive Ingredients

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, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol


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 productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Coppertone ®Sunscreen Lotion

Pure & Simple

100% Mineral Sun Protection

50

Free Of oxybenzone, octinoxate, PABA, parabens, dyes, fragrance

  • Hypoallergenic
  • Naturally sourced zinc oxide
  • With nourishing botanicals*

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Purpose

Sunscreen

Warnings

For external use only

Directions

■ shake well before each use

■ apply liberally 15 minutes before sun exposure

■ 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

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients (Active ingredients)

Zinc Oxide 24.08%

Inactive Ingredients (Inactive ingredients)

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, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, beeswax, hydroxyacetophenone, sodium chloride, 1,2-hexanediol, caprylyl glycol


Advanced Ingredient Data


Raw Label Data

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