P&s Lotion Spf 50

P&s Lotion Spf 50
SPL v4
SPL
SPL Set ID 081484f8-58f5-f2a4-e063-6394a90a3379
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
Ethylhexyl Isononanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Cyclomethicone 5 Ethylhexyl Pelargonate Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Ethylhexyl Methoxycrylene Triethoxycaprylylsilane Synthetic Beeswax Caprylyl Glycol 1,2-hexanediol Water Isopropyl Palmitate Butyloctyl Salicylate Dipropylene Glycol Tocopherol Hydroxyacetophenone Peg-12 Dimethicone Polyester-7 Dimethicone Sodium Chloride Alkyl (c12-15) Benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-06

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 productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone

Zinc Oxide Sunscreen

Pure&Simple

50

100% Mineral Sun Protection

Hypoallergenic

Sutable for Sensitive Skin

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

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

Active Ingredient

Zinc Oxide 24.08%

Other Information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

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


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 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

Zinc Oxide Sunscreen

Pure&Simple

50

100% Mineral Sun Protection

Hypoallergenic

Sutable 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

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

Active Ingredient (Active ingredient)

Zinc Oxide 24.08%

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

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


Advanced Ingredient Data


Raw Label Data

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