Label: LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM- avobenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51389-202-00 - Packager: Laura Geller Beauty, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 March 10, 2014
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- LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM
- USES
- WARNINGS
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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.
- Sun Protection Measures. Spending time in the sun increases your risk of skin 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:
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- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: Ask a doctor.
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INACTIVE INGREDIENTS
Water (Aqua), Glycerin, Mica, Octyldodecyl Neopentanoate, Butylene Glycol, Cyclopentsiloxane, Titanium Dioxide (CI 77891), Dimethicone, Camellia Sinensis Leaf Extract, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginia (Witch Hazel) Water, Centella Asiatica Extract, Lens Esculenta (Lentil) Seed Extract, Dimethiconol, Glyceryl Acrylate/Acrylic Acid Copolymer, PEG/PPG-18 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexandiol, Decylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499).
- Other Information
- Questions or comments?
- LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM 59ml (51389-202-00)
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INGREDIENTS AND APPEARANCE
LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51389-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) MICA (UNII: V8A1AW0880) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) DIMETHICONE (UNII: 92RU3N3Y1O) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GINKGO (UNII: 19FUJ2C58T) ALOE VERA LEAF (UNII: ZY81Z83H0X) HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V) CENTELLA ASIATICA (UNII: 7M867G6T1U) LENTIL (UNII: 6O38V6B52O) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) DECYLENE GLYCOL (UNII: S57M60MI88) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51389-202-00 1 in 1 PACKAGE 1 59 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/10/2014 Labeler - Laura Geller Beauty, LLC (199474524) Establishment Name Address ID/FEI Business Operations MANA Products, Inc. 078870292 manufacture(51389-202)
