Extreme Protect Spf 30

Extreme Protect Spf 30
SPL v10
SPL
SPL Set ID ecc4d304-e7e2-45b6-b9b2-2c64d3630860
Route
TOPICAL
Published
Effective Date 2018-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5.5 g) Zinc Cation (4.12 g)
Inactive Ingredients
Water Polyacrylamide (1500 Mw) Tocopherol Ethylhexyl Palmitate Ppg-3 Myristyl Ether Cetyl Alcohol Glycol Stearate Se Vinylpyrrolidone/hexadecene Copolymer Olea Europaea Leaf Aloe Vera Leaf Asiaticoside Asiatic Acid Madecassic Acid Sodium Dihydroxycetyl Phosphate Ethyl Linoleate Oleyl Alcohol Glyceryl Monostearate Octyldodecyl Neopentanoate Caprylyl Glycol Hexylene Glycol Peg-100 Stearate C13-14 Isoparaffin Laureth-7 Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01

Description

Octinoxate – 5.50% Zinc Oxide – 4.12%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

Octinoxate – 5.50% Zinc Oxide – 4.12%

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 if rash occurs

Section 50567-7

• When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

• Do not use on damaged or broken skin

Warnings

• For external use only

Directions
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 of 15 or higher and other sun protection measures including:

o limit time in the sun, especially from 10 a.m.-2 p.m.

o 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.

Active Ingredients

Octinoxate – 5.50%

Zinc Oxide – 4.12%

Inactive Ingredients

Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

Questions Or Comments?

Call Customer Care at (888) 804-4447

Package Label Principal Display Panel


Structured Label Content

Uses (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 if rash occurs

Section 50567-7 (50567-7)

• When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

• Do not use on damaged or broken skin

Purpose (PURPOSE)

SUNSCREEN

Warnings (WARNINGS)

• For external use only

Directions (DIRECTIONS)
  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

• Use a water resistant sunscreen if swimming or sweating

• Reapply 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 of 15 or higher and other sun protection measures including:

o limit time in the sun, especially from 10 a.m.-2 p.m.

o 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.

Active Ingredients

Octinoxate – 5.50%

Zinc Oxide – 4.12%

Inactive Ingredients

Water, Polyacrylamide, Tocopherol, Ethylhexyl Palmitate, PPG-3 Myristyl Ether, Cetyl Alcohol, Glycol Stearate SE, VP/Hexadecene Copolymer, Olea Europaea (Olive) Leaf Extract, Aloe Barbadensis Leaf Juice, Asiaticoside, Asiatic Acd, Madecassic Acid, Sodium Dihydrocetyl Phosphate, Ethyl Linoleate, Oleyl Alcohol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Caprylyl Glycol, Hexylene Glycol, PEG-100 Stearate, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol.

Questions Or Comments? (Questions or Comments?)

Call Customer Care at (888) 804-4447

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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