Label: BULLFROG LAND SPORT SPF 50 LIP BALM- avobenzone, octisalate, octocrylene and oxybenzone stick
-
Contains inactivated NDC Code(s)
NDC Code(s): 70281-339-03 - Packager: SolSkyn Personal Care 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 August 16, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
-
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
-
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Butylated Hydroxytolulene, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cyclomethicone, Diisobutyl Adipate, Dimethicone, Ethylhexyl Palmitate, Flavor, Glycine Soja (Soybean) Oil, Isostearyl Linoleate, Menthol, Ozokerite, Persea Gratissima (Avocado) Oil, Propylparaben, Saccharin, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl (Vitamin E) Acetate
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BULLFROG LAND SPORT SPF 50 LIP BALM
avobenzone, octisalate, octocrylene and oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-339 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM, OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y, OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) CYCLOMETHICONE (UNII: NMQ347994Z) DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) SOYBEAN OIL (UNII: 241ATL177A) ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N) MENTHOL (UNII: L7T10EIP3A) CERESIN (UNII: Q1LS2UJO3A) AVOCADO OIL (UNII: 6VNO72PFC1) PROPYLPARABEN (UNII: Z8IX2SC1OH) SACCHARIN (UNII: FST467XS7D) JOJOBA OIL (UNII: 724GKU717M) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-339-03 4.25 g in 1 CONTAINER; 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)
