Label: BULLFROG SPF50 LAND SPORT QUIK- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-338-13 - Packager: SolSkyn Personal Care LLC
- Category: HUMAN OTC DRUG LABEL
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 August 23, 2017
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
• 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
- Warnings
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Directions
• apply liberally 15 minutes before sun exposure
• re-apply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 broad spectrum SPF 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 shirts, pants, hats and sunglasses
• children under 6 months: ask a doctor
- Other information
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Inactive Ingredients
Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate, Fragrance, Glycerin, Hydroxypropylcellulose, Isopropyl Myristate, Lavender Extract, Phenethyl Benzoate, PPG-12/SMDI Copolymer, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (50.65% w/w), Tocopheryl (Vitamin E) Acetate
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BULLFROG SPF50 LAND SPORT QUIK
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-338 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 100 mg HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 15 mg in 100 mg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 100 mg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 mg in 100 mg OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mg in 100 mg Inactive Ingredients Ingredient Name Strength VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PHENETHYL BENZOATE (UNII: 0C143929GK) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ROSEMARY (UNII: IJ67X351P9) ALCOHOL (UNII: 3K9958V90M) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-338-13 147 mg in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/15/2015 Labeler - SolSkyn Personal Care LLC (080010329)
