YMLABS- spf30 flavored lip balm stick 
Yusef Manufacturing Laboratories

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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YMlabs SPF30 Flavored Lip Balm

SPF 30 Sunscreen

Uses: Helps prevent sunburn.
Directions: Apply evenly, 15
minutes before sun exposure.
Other: Protect this product from
excessive heat & direct sun.
Warnings: For external use only.
Children under 6 months: Ask a
doctor.

Drug Facts net wt 4.2g
Active Ingredients        Purpose

Meradimate (5%)...........Sunscreen

Octinoxate (7.5%).............Sunscreen

Octisalate (5%)..............Sunscreen
Oxybenzone (5%)...........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

SPF30 Flavored Lip Balm Template

YMLABS 
spf30 flavored lip balm stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10827-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE0.21 g  in 4.2 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.315 g  in 4.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.21 g  in 4.2 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.21 g  in 4.2 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
CERESIN (UNII: Q1LS2UJO3A)  
WHITE WAX (UNII: 7G1J5DA97F)  
MINERAL OIL (UNII: T5L8T28FGP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SACCHARIN (UNII: FST467XS7D)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10827-0008-14.2 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 finalpart35212/30/2021
Labeler - Yusef Manufacturing Laboratories (144150674)
Registrant - Yusef Manufacturing Laboratories (144150674)
Establishment
NameAddressID/FEIBusiness Operations
Yusef Manufacturing Laboratories144150674manufacture(10827-0008)

Revised: 1/2022
Document Id: 5e061b0b-dead-475d-a304-51d34afc6c2d
Set id: 739fcb06-e32c-42a3-98a8-7eab8faab219
Version: 1
Effective Time: 20220125
 
Yusef Manufacturing Laboratories