LIP BALM- octinoxate oxybenzone zinc oxide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Kamins Dermatologics Inc.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 75 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Sunscreen product 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

Authorization status:

OTC monograph final

Summary of Product characteristics

LIP BALM- OCTINOXATE OXYBENZONE ZINC OXIDE OINTMENT
KAMINS DERMATOLOGICS INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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CONSUMER LABELING
Active ingredients:
OCTINOXATE 7.5%
OXYBENZONE 5.0%
ZINC OXIDE 4.0%
Purpose: Sunscreen product
Keep out of the reach of children.
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
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.
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 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