YMLABS- spf30 flavored lip balm stick

YMLABS by

Drug Labeling and Warnings

YMLABS by is a Otc medication manufactured, distributed, or labeled by Yusef Manufacturing Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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>

SPL UNCLASSIFIED SECTION

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

WARNINGS

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.

INSTRUCTIONS FOR USE

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 INGREDIENT

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

YMLABS 
spf30 flavored lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10827-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	0.21 g  in 4.2 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.315 g  in 4.2 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g  in 4.2 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.21 g  in 4.2 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10827-0008-1	4.2 g in 1 TUBE; Type 0: Not a Combination Product	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/30/2021

Labeler - Yusef Manufacturing Laboratories (144150674)

Registrant - Yusef Manufacturing Laboratories (144150674)

Establishment
Name	Address	ID/FEI	Business Operations
Yusef Manufacturing Laboratories		144150674	manufacture(10827-0008)