Aquaphor Lip Protectant And Sunscreen

Aquaphor Lip Protectant And Sunscreen
SPL v10
SPL
SPL Set ID a43c2802-9cf1-477e-9f93-e11cf40b480d
Route
TOPICAL
Published
Effective Date 2015-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (31 g) Avobenzone (3 g) Octinoxate (6.75 g) Octisalate (4.5 g) Octocrylene (2 g) Oxybenzone (5.4 g)
Inactive Ingredients
Octyldodecanol Glycerin Castor Oil Panthenol Water Polyglyceryl-3 Diisostearate Shea Butter Alpha-tocopherol Acetate Hydrogenated Castor Oil Yellow Wax Magnesium Sulfate, Unspecified Magnesium Stearate Butylated Hydroxytoluene Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-30

Description

Active ingredients Petrolatum 31.0% Avobenzone 3.0% Octinoxate 6.75% Octisalate 4.5% Octocrylene 2.0% Oxybenzone 5.4%


Medication Information

Warnings and Precautions

Warnings

For external use only



Indications and Usage

Uses

•temporarily protects and helps relieve chapped or cracked lips

•helps protect lips from the drying effects of wind and cold weather

•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

Dosage and Administration

Directions

For sunscreen use: •apply liberally 15 minutes before sun exposure •reapply at least

every 2 hours •use a water resistant sunscreen if swimming or sweating

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-sleeved shirts,

pants, hats, and sunglasses

•children under 6 months of age: ask a doctor

Description

Active ingredients Petrolatum 31.0% Avobenzone 3.0% Octinoxate 6.75% Octisalate 4.5% Octocrylene 2.0% Oxybenzone 5.4%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if irritation occurs

Section 50567-7

When using this product avoid contact with eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Inactive ingredients C18-38 Alkyl Hydroxystearoyl Stearate, Octyldodecanol, Glycerin, Ricinus

Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Panthenol, Water, Polyglyceryl-3 Diisostearate,

Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Hydrogenated Castor Oil, Beeswax, C20-40 Alkyl

Stearate, Magnesium Sulfate, Magnesium Stearate, BHT.

Section 51945-4

Aquaphor Lip Protectant + Sunscreen

Repairs and Protects

For severly dry lips

Broad Spectrum SPF 30

Immediately soothes and helps heal severely dry lips



Fragrance free and Paraben free.

Section 53413-1

Questions

800-227-4703

Section 55105-1

Purpose

Skin Protectant

Sunscreen

Section 55106-9

Active ingredients

Petrolatum 31.0%

Avobenzone 3.0%

Octinoxate 6.75%

Octisalate 4.5%

Octocrylene 2.0%

Oxybenzone 5.4%


Structured Label Content

Indications and Usage (34067-9)

Uses

•temporarily protects and helps relieve chapped or cracked lips

•helps protect lips from the drying effects of wind and cold weather

•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

Dosage and Administration (34068-7)

Directions

For sunscreen use: •apply liberally 15 minutes before sun exposure •reapply at least

every 2 hours •use a water resistant sunscreen if swimming or sweating

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-sleeved shirts,

pants, hats, and sunglasses

•children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation occurs

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Inactive ingredients C18-38 Alkyl Hydroxystearoyl Stearate, Octyldodecanol, Glycerin, Ricinus

Communis (Castor) Seed Oil, Caprylic/Capric Triglyceride, Panthenol, Water, Polyglyceryl-3 Diisostearate,

Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Hydrogenated Castor Oil, Beeswax, C20-40 Alkyl

Stearate, Magnesium Sulfate, Magnesium Stearate, BHT.

Section 51945-4 (51945-4)

Aquaphor Lip Protectant + Sunscreen

Repairs and Protects

For severly dry lips

Broad Spectrum SPF 30

Immediately soothes and helps heal severely dry lips



Fragrance free and Paraben free.

Section 53413-1 (53413-1)

Questions

800-227-4703

Section 55105-1 (55105-1)

Purpose

Skin Protectant

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Petrolatum 31.0%

Avobenzone 3.0%

Octinoxate 6.75%

Octisalate 4.5%

Octocrylene 2.0%

Oxybenzone 5.4%


Advanced Ingredient Data


Raw Label Data

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