Aquaphor Lip Repair Stick + Sunscreen

Aquaphor Lip Repair Stick + Sunscreen
SPL v5
SPL
SPL Set ID d469bddf-90d4-7b1c-e053-2a95a90a1ed9
Route
TOPICAL
Published
Effective Date 2021-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Avobenzone (3 g) Octocrylene (9 g) Homosalate
Inactive Ingredients
Helianthus Annuus Seed Wax Cetostearyl Alcohol Hydrogenated Castor Oil Carnauba Wax Ascorbyl Palmitate Shea Butter Bis-diglyceryl Polyacyladipate-2 .alpha.-tocopherol Acetate Tocopherol Dimethicone Octyldodecanol Castor Oil Yellow Wax Jojoba Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-15

Description

Active ingredients: Avobenzone 3% Homosalate 9% Octisalate 4.5% Octocrylene 9%


Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not use on damaged or broken skin

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

Indications and Usage

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

Dosage and Administration

For sunscreen use

  • apply liberally at least 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two 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 SpectrumSPFvalue 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: Avobenzone 3% Homosalate 9% Octisalate 4.5% Octocrylene 9%

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 rash occurs

Section 51727-6

Inactive ingredients

Octyldodecanol, Ricinus Communis (Castor) Seed Oil, Beeswax, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Hydrogenated Castor OIl, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Alcohol, Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol.

Section 51945-4

Aquaphor Lip Repair Stick

+ Sunscreen

#1 Dermatologist Recommended Lip Care Brand

Repairs and Protects

For very dry lips

Broad spectrum SPF 30

Helps relieve dryness and soothe cracked, chapped lips

With Vitamins and Shea Butter

Fragrance Free and Paraben Free

Dermatologist recommended

Section 53413-1

Questions? 1-800-227-4703

Section 55105-1

Purpose:

Sunscreen

Section 55106-9

Active ingredients:

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

For sunscreen use

  • apply liberally at least 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every two 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 SpectrumSPFvalue 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

Do not use on damaged or broken skin

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

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 rash occurs

Section 51727-6 (51727-6)

Inactive ingredients

Octyldodecanol, Ricinus Communis (Castor) Seed Oil, Beeswax, Bis-Diglyceryl Polyacyladipate-2, Butyrospermum Parkii (Shea) Butter, Hydrogenated Castor OIl, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Alcohol, Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol.

Section 51945-4 (51945-4)

Aquaphor Lip Repair Stick

+ Sunscreen

#1 Dermatologist Recommended Lip Care Brand

Repairs and Protects

For very dry lips

Broad spectrum SPF 30

Helps relieve dryness and soothe cracked, chapped lips

With Vitamins and Shea Butter

Fragrance Free and Paraben Free

Dermatologist recommended

Section 53413-1 (53413-1)

Questions? 1-800-227-4703

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Section 55106-9 (55106-9)

Active ingredients:

Avobenzone 3%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%


Advanced Ingredient Data


Raw Label Data

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