LIP BALM description, usages, side effects, indications, overdosage, supplying and lots more!

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LIP BALM

J. A. Cosmetics U.S. INC
J. A. Cosmetics U.S. INC




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredients:

​OCTINOXATE (7.5%)

OXYBENZONE (5%)

Purpose

Purpose:

SUNSCREEN

Uses

Uses:

HELPS PREVENT SUNBURN

Warning:

For external use only

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 to help preven sunburn, not skin cancer or skin aging.

When Using This Product

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

Stop use and ask a doctor if

  • rash or irritation develops.

KEEP OUT OF REACH OF CHILDREN.

  • IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions:

  • APPLY LIBERALLY AS OFTEN AS NEEDED BEFORE SUN EXPOSURE.
  • REAPPLY AS NEEDED OR AFTER SWIMMING OR TOWEL DRYING.

Sun Protection Measures:

Spending time in the sun increases your risk of 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 shirt, pants, hats and sunglasses
  • Children under 6 months of age: Ask doctor.

OTHER INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • Store at room temperature 20°C - 25°C (68°F-77°F)

Inactive Ingredient:

polybutene, paraffinum liquidum (mineral oil), paraffin, microcrystalline wax (cera microcristallina), cersin, caprylic/capric triglyceride, polyethylene, bis-diglyceryl polyacryladipate-2, butyrospermum parkii (shea) butter, mentha piperita (peppermint)oil, polyglyceryl-4 isostearate, tocopheryl acetate (VE), phenoxyethanol, methylparaben, ethylparaben, butylparaben, isobutylparaben, propylparaben

May Contain: MICA, TITANUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 6 LAKE (CI 15985), RED 27 LAKE (CI 45410), RED 6 LAKE (CI 15850), RED 40 LAKE (CI 16035)

LIP BALM

LIP BALM

LIP BALM

OCTINOXATE, OXYBENZONE LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76354-110
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 7.5 g
OXYBENZONE OXYBENZONE 5 g

Inactive Ingredients

Ingredient Name Strength
POLYBUTENE (1400 MW)
Mineral Oil
PARAFFIN
MICROCRYSTALLINE WAX
Ceresin
MEDIUM-CHAIN TRIGLYCERIDES
HIGH DENSITY POLYETHYLENE
Adipic Acid
SHEA BUTTER
PEPPERMINT OIL
POLYGLYCERYL-4 ISOSTEARATE
.ALPHA.-TOCOPHEROL ACETATE
PHENOXYETHANOL
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
isobutylparaben
PROPYLPARABEN
MICA
titanium dioxide
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FD&C YELLOW NO. 6
D&C RED NO. 27
D&C RED NO. 6 BARIUM LAKE
FD&C RED NO. 40

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76354-110-41 2.1 in 1 TUBE
2 NDC:76354-110-51 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2014-06-10


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