Kids Tear Free Mineral Lotion Spf 50

Kids Tear Free Mineral Lotion Spf 50
SPL v5
SPL
SPL Set ID c054fd86-b0d9-24fc-e053-2a95a90aea2c
Route
TOPICAL
Published
Effective Date 2021-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14.5 g) Octisalate (5 g) Octinoxate (7.5 g)
Inactive Ingredients
Peg-12 Dimethicone/ppg-20 Crosspolymer Aloe Vera Leaf Ethylhexyl Palmitate Propylparaben Sodium Chloride Neopentyl Glycol Diheptanoate Triethoxycaprylylsilane Methylparaben Diazolidinyl Urea Water Cyclomethicone 5 Propylene Glycol Alkyl (c12-15) Benzoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5)

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-04

Description

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

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

#1 Pediatrician Recommended Brand

Coppertone ®Sunscreen Lotion

kids Tear Free

Stays on Strong Even in Water 50

Free Of oxybenzone, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

8 FL OZ (237 mL)

Warnings

For external use only

Questions

1-866-288-3330

Directions

■ shake well before 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

Other Information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

Inactive Ingredients

water, propylene glycol, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf extract, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride


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)

#1 Pediatrician Recommended Brand

Coppertone ®Sunscreen Lotion

kids Tear Free

Stays on Strong Even in Water 50

Free Of oxybenzone, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

8 FL OZ (237 mL)

Purpose

Sunscreen

Warnings

For external use only

Questions

1-866-288-3330

Directions

■ shake well before 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

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)

Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%

Inactive Ingredients (Inactive ingredients)

water, propylene glycol, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf extract, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride


Advanced Ingredient Data


Raw Label Data

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