All Good Broad Spectrum Spf 15 Spearmint Lip Balm

All Good Broad Spectrum Spf 15 Spearmint Lip Balm
SPL v2
SPL
SPL Set ID 77370d4e-6888-4cb7-b6b9-1011a71dbf7a
Route
TOPICAL
Published
Effective Date 2023-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (35 mg)
Inactive Ingredients
Calendula Officinalis Flower Comfrey Leaf Lavandula Angustifolia Flower Plantago Major Leaf Achillea Millefolium Flower Olive Oil Yellow Wax Spearmint Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-24

Description

Medicinal ingredients: Zinc Oxide 3.5%


Medication Information

Warnings and Precautions

Risk Information • For external use only • Do not use on damaged or broken skin • If rash occurs, discontinue use and consult a health care practitioner • When using this product keep out of eyes. • Rinse with water to remove.

Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, skin cancer or early skin aging.

Indications and Usage

Recommended Uses: Helps prevent sunburn.If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by sun.

Dosage and Administration

Directions • Apply liberally/generously (and evenly) 15 minutes before sun exposure. • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • after eating or drinking • For use on children less than 6 months of age, consult a health care practitioner. 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 • Use a water resistant sunscreen if swimming or sweating.

Description

Medicinal ingredients: Zinc Oxide 3.5%

Section 50565-1

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

Section 51727-6



Non-medicinal Ingredients : Organic Olea Europaea (Extra Virgin Olive) Fruit Oil, Cera Alba (Beeswax), Organic Calendula Officinalis (Calendula) Flower, Organic Symphytum Officinale (Comfrey) Leaf, Organic Plantago Lanceolata (Plantain) Leaf, Organic Lavandula Angustifolia (Lavender) Flower, Organic Achillea Millefolium (Yarrow) Flower, Organic Mentha Spicata (Spearmint Essential Oil), Non-GMO Tocopherol (Vitamin E).

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Medicinal ingredients: Zinc Oxide 3.5%

Product Package Labeling

BROAD SPECTRUM SPF 15

ALL

good

SPEARMINT

lip balm

Net wt 0.15 oz (4.2 g)

P.O. BOX 203, MORRO BAY, CA 93443 | ALLGOODBODYCARE.COM

res


Structured Label Content

Indications and Usage (34067-9)

Recommended Uses: Helps prevent sunburn.If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by sun.

Dosage and Administration (34068-7)

Directions • Apply liberally/generously (and evenly) 15 minutes before sun exposure. • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • after eating or drinking • For use on children less than 6 months of age, consult a health care practitioner. 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 • Use a water resistant sunscreen if swimming or sweating.

Warnings and Precautions (34071-1)

Risk Information • For external use only • Do not use on damaged or broken skin • If rash occurs, discontinue use and consult a health care practitioner • When using this product keep out of eyes. • Rinse with water to remove.

Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, skin cancer or early skin aging.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)



Non-medicinal Ingredients : Organic Olea Europaea (Extra Virgin Olive) Fruit Oil, Cera Alba (Beeswax), Organic Calendula Officinalis (Calendula) Flower, Organic Symphytum Officinale (Comfrey) Leaf, Organic Plantago Lanceolata (Plantain) Leaf, Organic Lavandula Angustifolia (Lavender) Flower, Organic Achillea Millefolium (Yarrow) Flower, Organic Mentha Spicata (Spearmint Essential Oil), Non-GMO Tocopherol (Vitamin E).

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Medicinal ingredients: Zinc Oxide 3.5%

Product Package Labeling

BROAD SPECTRUM SPF 15

ALL

good

SPEARMINT

lip balm

Net wt 0.15 oz (4.2 g)

P.O. BOX 203, MORRO BAY, CA 93443 | ALLGOODBODYCARE.COM

res


Advanced Ingredient Data


Raw Label Data

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