Otc - Active Ingredient
Medicinal ingredients: Zinc Oxide 3.5%
All Good Broad Spectrum Spf 15 Spearmint Lip Balm Stick
FDA Label NDC 65692-0313
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose, Inc. for the product All Good Broad Spectrum Spf 15 Spearmint Lip Balm (NDC 65692-0313). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, other, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, product package labeling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Other
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.
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.
Dosage & 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.
Inactive Ingredient
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).
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
* Please review the disclaimer below.
