SURF BAY LIP BALM- lip balm gel
Universal Packaging Systems, Inc. DBA: PakLab

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.

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Octinoxate 7.5%

Help protect again sunburn and chapped lips

Warnings: Keep out of reach of children

Apply liberaly 15 minutes before sun exposure

Hydrogenated Soybean Oil, Butyrospermum Parkii (Shea) Butter, Beeswax (CERA ALBA), Limnanthes Alba (Meadowfoam) Seed Oil, C10-18 Triglycerides, Hydrogenated Soy Polyglycerides, Flavor (Aroma), Propylene Glycol Myristyl Ether Acetate, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Salicylic Acid, Tocopheryl Acetate, C15-23 Alkane,

Sclerocarya Birrea Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Cinnamal, Sucralose, Myristyl Alcohol, Propylene Glycol, Acetic Acid.

Questions or Comments? 702-347-1229 or email info@baysoleil.com

Keep out of reach of children

Helps protect against sunburn and chapped lips

Topical gel

Surfbay Display panel jpg

SURF BAY LIP BALM
lip balm gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61531-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61531-100-01	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/25/2015

Labeler - Universal Packaging Systems, Inc. DBA: PakLab (790530976)