SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM ULTA- avobenzone 2.00% octisalate 3.00% octocrylene 7.00% oxybenzone 3.00% stick

SPF 30 tropical flavor sunscreen lip balm by

Drug Labeling and Warnings

SPF 30 tropical flavor sunscreen lip balm by is a Otc medication manufactured, distributed, or labeled by Ulta, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                                          Purpose
Avobenzone 2.00%........................................................................Sunscreen
Octisalate 3.00%............................................................................Sunscreen
Octocrylene 7.00%.........................................................................Sunscreen
Oxybenzone 3.00%........................................................................Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product Keep out of eyes. Rinse eyes with water to remove.
Keep away from face to avoid breathing it Do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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 this 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 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Ascorbyl Palmitate
Beeswax
BHT
Cetyl Alcohol
Ethylhexyl Palmitate
Euphorbia Cerifera (Candelilla) Wax
Fragrance
Ozokerite
Paraffin
Polyester-8
Polyethylene
Propylparaben
Retinyl Palmitate
Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM  ULTA
avobenzone 2.00% octisalate 3.00% octocrylene 7.00% oxybenzone 3.00% stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62296-7780
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	2 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	3 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	7 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
ALOE (UNII: V5VD430YW9)
Ascorbic Acid (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Cetyl Alcohol (UNII: 936JST6JCN)
PUMMELO (UNII: ET1TN5W71X)
LEMON PEEL (UNII: 72O054U628)
CUCUMBER (UNII: YY7C30VXJT)
Diisobutyl Adipate (UNII: 8OPY05ZY7S)
Dimethicone (UNII: 92RU3N3Y1O)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
Ethylhexyl Palmitate (UNII: 2865993309)
GINKGO (UNII: 19FUJ2C58T)
Hydrated Silica (UNII: Y6O7T4G8P9)
Isostearyl Linoleate (UNII: 4778M3HR0N)
CERESIN (UNII: Q1LS2UJO3A)
ASIAN GINSENG (UNII: CUQ3A77YXI)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ROSEMARY (UNII: IJ67X351P9)
SALIX ALBA BARK (UNII: 205MXS71H7)
SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Trisiloxane (UNII: 9G1ZW13R0G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62296-7780-1	0.14 g in 1 TUBE; Type 0: Not a Combination Product	01/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/27/2016

Labeler - Ulta (608168597)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(62296-7780) , label(62296-7780)