GLO SKIN BEAUTY BALM MINT SPF 15- glo skin beauty balm mint spf 15 stick
Hayden Caleel LLC

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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DRUG FACTS

Active Ingredients

Octinoxate 7.5%
Oxybenzone 3%

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Agining Alert: Spending time in the sun increases your skin cancer and early skin aging. This product has been shown only to prevent sunberun, not skin cancer or early skin aging.

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Inactive ingredients

Helianthus Annuus (Sunflower) Seed Oil, Glycine Soja (Soybean) Oil, Beeswax, Euphorbia Cerifera (Candalila) Wax, Cannabis Sativa Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Mangifera Indica (Mango) Seed Butter, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbaensis Leaf Extract, Tocopherol

Other Information

• protect the product in this container from excessive
heat and direct sun

Principal Display Panel

60541-1500-1

GLO SKIN BEAUTY BALM MINT SPF 15
glo skin beauty balm mint spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60541-1500
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SOYBEAN OIL (UNII: 241ATL177A)
CANDELILLA WAX (UNII: WL0328HX19)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60541-1500-1	1 in 1 CARTON	12/31/2017
1		18 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	12/31/2017

Labeler - Hayden Caleel LLC (011367468)