Drug Facts

Active Ingredients

Octinoxate 7.5%

Octocrylene 5%

Zinc Oxide 3%

Avobenzone 3%

Titanium Dioxide 1.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn.
If used as directed with other sun protection decreases the risk of cancer and early skin aging caused by the sun.

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.

Keep out of reach of children

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

Directions

Apply generously 15 minutes before sun exposure.
Children under 6 months of age: ask a doctor
Use a water resistant sunscreen if swimming or sweating.
Reapply at lease 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 value 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 sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in its container from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polybutene, Disteardimonium Hectorite, Sodium Chloride, Butylene Glycol, Phenoxyethanol, PEG/PPG-18/18 Dimethicone, Propylene Glycol, Sodium Dehydroacetate, Decylene Glycol, Fragrance/Parfum, Methicone, Disodium EDTA, Tocopheryl Acetate, Lauroyl Lysine, Butylphenyl Methylpropional, Limonene, Geraniol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Linalool. May Contain (+/-): Talc, Hydrogen Dimethicone, Aluminum Hydroxide, Iron Oxides (CI 77491, CI 77492, CI 77499).

Product Labels

ShadeLabel tube label

BLURRED LINES CC CREME BROAD SPECTRUM SPF 20 SHADE 03 MEDIUM/DARK
octinoxate, octocrylene, zinc oxide, avobenzone, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69549-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAUROYL LYSINE (UNII: 113171Q70B)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
GERANIOL (UNII: L837108USY)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description
Packaging
1	NDC:69549-003-01	1 in 1 CARTON
1		30 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/20/2015

Labeler - Color Prevails LLC (079427419)

Blurred Lines CC Creme Broad Spectrum SPF 20 Shade 03 Medium/Dark