KISS MY FACE SPF 30 LIP BALM- avobenzone, homosalate, octinoxate, octocrylene stick

Kiss My Face SPF 30 Lip Balm by

Drug Labeling and Warnings

Kiss My Face SPF 30 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Kiss My Face, OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone (3.0%), Homosalate (8.0%), Octinoxate (7.0%), Octocrylene (2.0%)

Purpose

Sunscreen

Keep Out of Reach of Children

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

Uses

Helps prevent sunburn.

Warnings

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 doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 AM – 2 PM . Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Extract*, Butyrospermum Parkii (Shea Butter), Calendula Officinalis Flower Extract*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Geranium Maculatum Extract*, Hippophae Rhamnoides Oil, Lecithin*, Pelargonium Graveolens Flower Oil Rosa Canina, Extract*,Sambucus Nigra Flower Extract*,

Tocophero.*Organic

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

KISS MY FACE SPF 30 LIP BALM 
avobenzone, homosalate, octinoxate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65364-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)	38 mg  in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	37.5 mg  in 1 g
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)	2.0 mg  in 1 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	1.20 mg  in 1 g
SHEA BUTTER (UNII: K49155WL9Y)	.1 mg  in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65364-220-01	1 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/09/2014

Labeler - Kiss My Face (041794279)

Registrant - Kiss My Face (041794279)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(65364-220) , LABEL(65364-220)