Acaifusion Lip Balm Broad Spectrum Spf 30

Acaifusion Lip Balm Broad Spectrum Spf 30
SPL v13
SPL
SPL Set ID f28e729f-0dd8-4517-855b-0b8dd645053a
Route
TOPICAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.44 g) Octinoxate (1.11 g) Octisalate (0.74 g)
Inactive Ingredients
Ascorbyl Palmitate Sunflower Oil Aloe Vera Leaf Castor Oil D&c Red No. 27 Coconut Petrolatum Ceresin Yellow Wax Polyester-7 Neopentyl Glycol Diheptanoate Sorbitan Monooleate Candelilla Wax Carnauba Wax Polysilicone-15 Soybean Oil Tocopherol Shea Butter Honey

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-06-28

Description

Active Ingredients                                                    Purpose Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     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.

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.

- 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.

- wear long-sleeve shirts, pants, hats, and sunglasses

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

Description

Active Ingredients                                                    Purpose Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     Sunscreen

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 51727-6

Inactive Ingredients-Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) Wax, Polysilicone-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

Play Lip Balm SPF 30 with Acai

Section 55105-1

Uses

-Helps prevent and temporarily 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

Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     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.

- 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.

- wear long-sleeve shirts, pants, hats, and sunglasses

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

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 product is swallowed, get medical help or

contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredients-Petrolatum, Ozokerite, Beeswax, Polyester-7, Neopentyl Glycol Diheptanoate, Flavor, Sorbitan Oleate, Euphorbia Cerifera (Candelilla) Wax, Polysilicone-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)

Play Lip Balm SPF 30 with Acai

Section 55105-1 (55105-1)

Uses

-Helps prevent and temporarily 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

Avobezone 3%, Octinoxate 7.5%, Octisalate 5%     Sunscreen


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)