MD GLAM SPF 50- octinoxate lotion

MD Glam SPF 50 by

Drug Labeling and Warnings

MD Glam SPF 50 by is a Otc medication manufactured, distributed, or labeled by Spa de Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Zinc oxide 9.5%

Purpose

Sunscreen

Warnings

Warnings

• For external use only
• Do not use on damaged or broken skin

When using this product

• keep out of the eye area
• rinse with water to remove
• stop use and ask a doctor if rash or irritation develops
• for external use onlyl
• keep out of reach of children

Jar is glass and may shatter if dropped

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

Directions

Directions

Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Inactive Ingredients:

aqua, cocos nucifera (coconut) oil, carthamus tinctoris (safflower) seed oil, heptyl undecylenate, caprylic/capric triglyceride, cetyl alcohol, glycerin

Principal Display Panel

INGREDIENTS AND APPEARANCE

MD GLAM SPF 50 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68062-9000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 mg  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
SAFFLOWER SEED (UNII: 8FCL6A31TX)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68062-9000-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/14/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/14/2022

Labeler - Spa de Soleil (874682867)

Establishment
Name	Address	ID/FEI	Business Operations
Spa de Soleil		874682867	manufacture(68062-9000)