Mint Fusion Lip Balm

Mint Fusion Lip Balm
SPL v9
SPL
SPL Set ID 25f0dd2a-0465-49fb-ba11-f3596df2d968
Route
TOPICAL
Published
Effective Date 2017-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.11 g) Octisalate (0.74 g) Avobenzone (0.44 g)
Inactive Ingredients
Yellow Wax Ceresin Candelilla Wax Carnauba Wax Honey Ascorbyl Palmitate Aloe Vera Leaf Sorbitan Monooleate Polysilicone-15 Tocopherol .alpha.-tocopherol Acetate Menthone 1,2-glycerol Ketal, (-)- Menthol Spearmint Oil Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-08-31

Description

Active Ingredients Purpose Avobenzone 3.0% Sunscreen Ocinoxate 7.5% Sunscreen Octisalate 5.0% Sunscreen


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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

· Apply liberally 15 minutes before sun exposure

-Reapply liberally as often as necessary

· Use a water resistant sunscreen if swimming or sweating

· Children under 6 months: Ask a doctor

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 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.

Description

Active Ingredients Purpose Avobenzone 3.0% Sunscreen Ocinoxate 7.5% Sunscreen Octisalate 5.0% Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (coconut) Fruit Extract

Section 51945-4

Supergoop SPF 30

Soothe

Protect

Hydrate

MintFusion Lip Balm with Shea Butter

.50 Fl Oz

Section 55105-1

Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and/or lips. 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 55106-9

Active Ingredients Purpose

Avobenzone 3.0% Sunscreen

Ocinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

· Apply liberally 15 minutes before sun exposure

-Reapply liberally as often as necessary

· Use a water resistant sunscreen if swimming or sweating

· Children under 6 months: Ask a doctor

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 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.

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. If swallowed, get medical help or contact a poison control center right away. If condition worsens or does not improve within 7 days, consult a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients- Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) wax, Copernicia cerifera (carnauba) Wax, Polysiilicone-15, Glycine Soja (Soybean) Oil, Tocopherol, Butyrospermum Parkii (Shea) Butter, Honey, Ascorbyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Ricinus Communis (Castor) Seed Oil, Red 27 Lake, Cocos Nucifera (coconut) Fruit Extract

Section 51945-4 (51945-4)

Supergoop SPF 30

Soothe

Protect

Hydrate

MintFusion Lip Balm with Shea Butter

.50 Fl Oz

Section 55105-1 (55105-1)

Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and/or lips. 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 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3.0% Sunscreen

Ocinoxate 7.5% Sunscreen

Octisalate 5.0% Sunscreen


Advanced Ingredient Data


Raw Label Data

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