TEA TREE LIP BALM, SPF 15- octinoxate, oxybenzone stick

Tea Tree Lip Balm, SPF 15 by

Drug Labeling and Warnings

Tea Tree Lip Balm, SPF 15 by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Octinoxate (2.0%), Oxybenzone (4.5%)

Purpose

Sunscreen

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Prevents Sunburns

Warnings

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

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

TEA TREE LIP BALM, SPF 15 
octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	20 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	45 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)	304 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	305 mg  in 1 g
ACETYLATED LANOLIN (UNII: 2X654GD19H)	97 mg  in 1 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63645-176-03	4 g in 1 CONTAINER; Type 0: Not a Combination Product	10/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	352	10/09/2017

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	manufacture(63645-176) , label(63645-176) , analysis(63645-176)