Label: MALLY LIP DEFENDER- avobenzone, octinoxate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76119-5305-1 - Packager: MallyGirl, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 1, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Use
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
MALLY LIP DEFENDER
avobenzone, octinoxate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76119-5305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.07 g in 3.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .245 g in 3.5 g Inactive Ingredients Ingredient Name Strength POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) SUNFLOWER OIL (UNII: 3W1JG795YI) OCTYLDECANOL (UNII: 07UG7TSU58) CANDELILLA WAX (UNII: WL0328HX19) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) HYALURONIC ACID (UNII: S270N0TRQY) TOCOPHEROL (UNII: R0ZB2556P8) ALUMINUM OXIDE (UNII: LMI26O6933) STANNIC OXIDE (UNII: KM7N50LOS6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 6 (UNII: 481744AI4O) D&C RED NO. 7 (UNII: ECW0LZ41X8) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76119-5305-1 1 in 1 BOX 1 3.5 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2012 Labeler - MallyGirl, LLC (167262554)
