mally Lip Defender description, usages, side effects, indications, overdosage, supplying and lots more!

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mally Lip Defender

MallyGirl, LLC

mally Lip Defender - Invincible Rose - Broad Spectrum SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DRUG FACTS


Active Ingredients

Avobenzone 2.0%

Octinoxate 7.0%

Purpose

Sunscreen

Sunscreen

Use

  • 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.

For external use only

Do not use on damaged or broken skin.

Stop use and ask doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swollowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: ask a doctor.
  • Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including:
  • Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2  triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba),  Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)

Other Information

  • Protect this product from excessive heat and direct sun.

Principal Display Panel

mally






mally Lip Defendermally Lip Defender

mally Lip Defender

AVOBENZONE, OCTINOXATE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76119-5307
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 0.07 g
OCTINOXATE OCTINOXATE .245 g

Inactive Ingredients

Ingredient Name Strength
POLYBUTENE (1400 MW)
SUNFLOWER OIL
OCTYLDECANOL
CANDELILLA WAX
TRIHYDROXYSTEARIN
carnauba wax
MICROCRYSTALLINE WAX
.ALPHA.-TOCOPHEROL ACETATE
SILICON DIOXIDE
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)
SACCHAROMYCES CEREVISIAE
HYALURONIC ACID
Tocopherol
ALUMINUM OXIDE
STANNIC OXIDE
titanium dioxide
MICA
D&C RED NO. 28
FD&C YELLOW NO. 5
D&C RED NO. 6
D&C RED NO. 7
FD&C YELLOW NO. 6
ferric oxide red
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 3.5 in 1 TUBE, WITH APPLICATOR
2 NDC:76119-5307-1 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-05-01


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