Label: BLURRED LINES CC CREME BROAD SPECTRUM SPF 20 SHADE 01 LIGHT- octinoxate, octocrylene, zinc oxide, avobenzone, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69549-001-01 - Packager: Color Prevails LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 17, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
BLURRED LINES CC CREME BROAD SPECTRUM SPF 20 SHADE 01 LIGHT
octinoxate, octocrylene, zinc oxide, avobenzone, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69549-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69549-001-01 1 in 1 CARTON 1 30 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/17/2015 Labeler - Color Prevails LLC (079427419)
