Active Ingredients
ZINC OXIDE 11%
All Weather Spf 15 Lip Balm Stick
FDA Label NDC 26052-036
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Burt's Bees for the product All Weather Spf 15 Lip Balm (NDC 26052-036). 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 active ingredients, purpose, uses, warnings:, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
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.
Warnings:
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of reach of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Reappy after 40 minutes of swimming or weating.
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 of 15 or higher and other sun protection measuresincluding:
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 consult a doctor.
Inactive Ingredients:
beeswax, olea europaea (olive) fruit oil, theobroma cacao (cocoa) seed butter, simmondsia chinensis (jojoba) seed oil, isoamyl laurate, butyrospermum parkii (shea) butter, flavor, limnanthes alba (meadowfoam) seed oil, citrus aurantium dulcis (orange) peel wax, jojoba esters, glycine soja (soybean) oil, tocopherol, citric acid, rebaudioside A, polyhydroxystearic acid
Other Information:
Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
BURTS BEES
ALL WEATHER SPF 15
MOISTURIZING LIP BALM
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