OTC Medication Information: Ultra Color Absolute

ULTRA COLOR ABSOLUTE- octinoxate lipstick
New Avon LLC

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.

Active ingredient
Octinoxate 7.5%………………………………………

Purpose
……………………………Sunscreen

Uses
• helps prevent sunburn

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 help prevent sunburn, not skin cancer or early skin aging.
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

​For sunscreen use:
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating

Other information

• protect the product in this container from excessive heat and direct sun

Inactive Ingredients:
DIISOPROPYL DIMER DILINOLEATE, LANOLIN, DI-PPG-3 MYRISTYL ETHER ADIPATE, TRIDECYL TRIMELLITATE, SYNTHETIC WAX, POLYBUTENE, STEARYL/PPG-3 MYRISTYL ETHER DIMER DILINOLEATE, SILICA, MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, DIPHENYL DIMETHICONE, PHENYL TRIMETHICONE, OZOKERITE, DILAURYL THIODIPROPIONATE, GLYCERIN, LAURYL PCA, NYLON-12, PHYTOL, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, DIPALMITOYL HYDROXYPROLINE, ETHYLENE/
PROPYLENE/STYRENE COPOLYMER, TRIETHYL CITRATE, ACRYLATES COPOLYMER, PARFUM/FRAGRANCE, ACRYLATES/CARBAMATE COPOLYMER, PALMITIC ACID, C12-15 ALKYL BENZOATE, WATER/EAU, DIMETHICONE, COLLAGEN, TRIBEHENIN, BUTYLENE/ETHYLENE/STYRENE COPOLYMER,
SACCHARIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, CERAMIDE 2, PEG-10 RAPESEED STEROL, CAMELLIA SINENSIS LEAF EXTRACT, ASCORBIC ACID, BUTYROSPERMUM PARKII (SHEA) BUTTER, SILICA DIMETHYL SILYLATE, BEESWAX/CIRE D’ABEILLE, POLYESTER-1, PALMITOYL OLIGOPEPTIDE, PEG-200. SHIMMER SHADES MAY ALSO CONTAIN: CALCIUM SODIUM BOROSILICATE, BARIUM SULFATE, TIN OXIDE. MAY CONTAIN: RED 7 LAKE/CI 15850, TITANIUM DIOXIDE/CI 77891, RED 6 LAKE/CI 15850, IRON OXIDES, MICA/CI 77019, YELLOW 5 LAKE/CI 19140, YELLOW 6 LAKE/CI 15985, BLUE 1 LAKE/CI 42090, RED 33 LAKE/CI 17200, RED 27 LAKE/CI 45410, CARMINE/CI 75470.

Questions or Comments?
Call toll free 1-800-FOR-AVON or 1-800-265-AVON in Canada

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ULTRA COLOR ABSOLUTE
octinoxate lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0325
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10096-0325-2 1 PACKAGE in 1 CARTON contains a PACKAGE (10096-0325-1)
1 NDC:10096-0325-1 3 g in 1 PACKAGE This package is contained within the CARTON (10096-0325-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/19/2014
Labeler — New Avon LLC (080143520)
Establishment
Name Address ID/FEI Operations
Avon Cosmetics Manofacturing, S. de R.L. de C.V. 815033493 manufacture (10096-0325)

Revised: 02/2016 New Avon LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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