Eclipse Spf 50 Non Tinted

Eclipse Spf 50 Non Tinted
SPL v8
SPL
SPL Set ID 49df51e6-be9a-41be-b3e1-bfc062aaceaa
Route
TOPICAL
Published
Effective Date 2014-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.2 g) Zinc Cation (1.1 g)
Inactive Ingredients
Peg-100 Stearate Polyhydroxystearic Acid (2300 Mw) Sorbitan Monolaurate Styrene Tocopherol .alpha.-tocopherol Acetate Triethoxycaprylylsilane Vinylpyrrolidone/eicosene Copolymer Water Xanthan Gum Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow 1,2-hexanediol Aluminum Butylene Glycol Alkyl (c12-15) Benzoate Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Cetearyl Glucoside Edetate Disodium Glyceryl Monostearate Octyldodecyl Neopentanoate

Identifiers & Packaging

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

Description

TITANIUM DIOXIDE – 5.20% Zinc Oxide – 1.10%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

TITANIUM DIOXIDE – 5.20% Zinc Oxide – 1.10%

Uses

• Helps hydrate and 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.
  • REAPPLY:
  • AFTER 40 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 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

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Active Ingredients

TITANIUM DIOXIDE – 5.20%

Zinc Oxide – 1.10%

Inactive Ingredients

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alumina, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Dimethicone, Glyceryl Stearate, Methicone, Octyldodecyl Neopentanoate, PEG-100 Stearate, Polyhydroxystearic Acid, Sorbitan Laurate, Styrene/Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Aqua/Eau, Xanthan Gum +/- Iron Oxides.

Questions Or Comments?

Call Customer Care at (888) 804-4447

Package Label Principal Display Panel


Structured Label Content

Uses (USES)

• Helps hydrate and 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.
  • REAPPLY:
  • AFTER 40 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 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

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

Active Ingredients

TITANIUM DIOXIDE – 5.20%

Zinc Oxide – 1.10%

Inactive Ingredients

1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alumina, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Disodium EDTA, Dimethicone, Glyceryl Stearate, Methicone, Octyldodecyl Neopentanoate, PEG-100 Stearate, Polyhydroxystearic Acid, Sorbitan Laurate, Styrene/Acrylates Copolymer, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Aqua/Eau, Xanthan Gum +/- Iron Oxides.

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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