YMLABS- spf15 flavored lip balm stick 
Yusef Manufacturing Laboratories

----------

YMlabs SPF15 Flavored Lip Balm

SPF 15Sunscreen

LIP MOISTURIZER

Drug Factsnet wt 4.2g
Active Ingredients        Purpose
Octinoxate (7%).............Sunscreen
Oxybenzone (4%)...........Sunscreen

Made in the USA

Distributed by
<Vendor, City, ST>

Drug Facts(continued)
Uses: • Helps prevent sunburn • Higher SPF gives
more sunburn protection.

Warnings: For external use only.When using this
product: • Keep out of eyes • Rinse with water to remove
• Stop use and ask a doctor if rash or irritation develops
and lasts.

Directions:• Apply evenly 15 minutes before sun
exposure and as needed • Reapply at least every 2
hours • Children under 6 months of age: ask a doctor.

Inactive Ingredients:Petrolatum, Ozokerite,
Beeswax, Mineral Oil, Coconut Oil, Flavor, Saccharin,
Phenyl Trimethicone, Safflower Seed Oil, Aloe Oil,
Vitamin E Acetate

Other Information:Moderate sun protection product
• Sun Alert: Limiting sun exposure, wearing protective
clothing, and using sunscreens may reduce the risks of
skin aging, skin cancer, and other harmful effects of the
sun.
Questions?877.827.5425

SPF15 Flavored Lip Balm Template

YMLABS 
spf15 flavored lip balm stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.168 g  in 4.2 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.294 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CERESIN (UNII: Q1LS2UJO3A)  
WHITE WAX (UNII: 7G1J5DA97F)  
MINERAL OIL (UNII: T5L8T28FGP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SACCHARIN CALCIUM (UNII: 5101OP7P2I)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
ALOE (UNII: V5VD430YW9)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10827-0004-14.2 g in 1 TUBE; Type 0: Not a Combination Product12/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drugpart35212/30/2021
Labeler - Yusef Manufacturing Laboratories (144150674)
Registrant - Yusef Manufacturing Laboratories (144150674)
Establishment
NameAddressID/FEIBusiness Operations
Yusef Manufacturing Laboratories144150674manufacture(10827-0004)

Revised: 4/2024
 
Yusef Manufacturing Laboratories