FDA Label for Lip Balm
View Indications, Usage & Precautions
Lip Balm Product Label
The following document was submitted to the FDA by the labeler of this product Kamins Dermatologics Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients:
OCTINOXATE 7.5%
OXYBENZONE 5.0%
ZINC OXIDE 4.0%
Otc - Purpose
Purpose: Sunscreen product
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Indications & Usage
A soothing treatment balm that helps heal and protect lips from sun, wind and extreme tempera- tures. Repairs happed, sore lips with Bio-MapleTM compound and skin softening oils. Also helps prevent the breakout of lip sores with broad spectrum UVA/UVB sun screening agents. Creates a smoother palette for lipstick application by diminishing the appearance of lip lines and reducing the feathering of lip color. Use anytime for fuller, more luscious lips
Uses
helps prevent sunburn
higher SPF gives more sunburn protection
provides moderate protection against sunburn
Warnings
Warnings
For external use only.
When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
If swallowed, seek medical assistance or contact a Poison Control
Center immediately.
Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
Dosage & Administration
Directions
Using the angled tube applicator, squeeze tube and apply directly to lips 15-30 minutes before sun exposure. Reapply as needed, especially after prolonged sun exposure, drinking or eating.
Children under 6 months of age: ask a doctor.
Inactive Ingredient
Inactive ingredients: Polybutene, ricinus communis (castor) seed oil, petrolatum, VP/hexadecene copolymer, cera alba (beeswax), cyclopentasiloxane/dimethicone crosspolymer, caprylic/capric triglyceride, squalane, copernicia cerifera (carnauba wax), paraffin, tocopheryl acetate, acer saccharum (maple isolate), flavour/aroma, benzyl benzoate.
B. Kamins Lip Balm Spf 20 Box
B. KAMINS
LIP BALM SPF 20
15 G / 0.5 oz
DIN 02248084
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