SPL v3
SPL
SPL Set ID 1e3db995-b1c5-3a2e-e063-6294a90af75e
Route
TOPICAL
Published
Effective Date 2024-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (60 mg) Octocrylene (30 mg) Zinc Oxide (80 mg)
Inactive Ingredients
Alpha-tocopherol Acetate Silica Dimethyl Silylate Tribehenin Bemotrizinol Methyl Salicylate Stevia Rebaudiana Leaf Polyglyceryl-3 Pentaricinoleate Ricinus Communis Seed Ceresin Butyrospermum Parkii (shea) Butter Unsaponifiables Diethylamino Hydroxybenzoyl Hexyl Benzoate Triacontanyl Pvp (wp-660) Medium-chain Triglycerides Alkyl (c12-15) Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-22

Description

Zinc Oxide 8% Homosalate 6% Octocrylene 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Dosage and Administration

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Description

Zinc Oxide 8% Homosalate 6% Octocrylene 3%

Uses

Helps prevent sunbum

If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and earty skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs

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

Directions

Apply generously and evenly 15 minutes before sun exposure • reapply at least every 80 minutes • 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, regularty use a sunscreen with broad spectrum SPF 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 the product in this container from excessive heat and direct sun

Active Ingredients

Zinc Oxide 8%

Homosalate 6%

Octocrylene 3%

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Caprylic/capric Triglyceride, Ozokerite, C12-15 Alkyl| Benzoate, Butyrospermum Parki (Shea) Butter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Tribehenin, Silica Dimethyl Silylate, Polyglyceryl-3 Polyricinoleate, Bis-Ethythexyloxyphenol Methoxypheny! Triazine, Flavor, Triacontanyl Pup,Tocopheryl Acetate, Stevia Rebaudiana Leaf

Keep Out of Reach of Children

Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away

Package Label. Principal Display Panel

Standard Procedure

Lipbalm SPF 50+

Coconut

Broad Spectrum UVA/UVB

5g 0.17oz.

IMAGE Lip Balm 240410.jpg


Structured Label Content

Uses

Helps prevent sunbum

If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and earty skin aging caused by the sun

Dosage and Administration (34068-7)

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Warnings

For external use only

Do not use on damaged or broken skin • Stop use and ask a doctor if rash occurs

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

Directions

Apply generously and evenly 15 minutes before sun exposure • reapply at least every 80 minutes • 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, regularty use a sunscreen with broad spectrum SPF 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 the product in this container from excessive heat and direct sun

Active Ingredients

Zinc Oxide 8%

Homosalate 6%

Octocrylene 3%

Inactive Ingredients

Ricinus Communis (Castor) Seed Oil, Caprylic/capric Triglyceride, Ozokerite, C12-15 Alkyl| Benzoate, Butyrospermum Parki (Shea) Butter, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Tribehenin, Silica Dimethyl Silylate, Polyglyceryl-3 Polyricinoleate, Bis-Ethythexyloxyphenol Methoxypheny! Triazine, Flavor, Triacontanyl Pup,Tocopheryl Acetate, Stevia Rebaudiana Leaf

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center right away

Package Label. Principal Display Panel

Standard Procedure

Lipbalm SPF 50+

Coconut

Broad Spectrum UVA/UVB

5g 0.17oz.

IMAGE Lip Balm 240410.jpg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)