Otc - Active Ingredient
Active ingredient
Octinoxate 7.5%.............................................
The following Structured Product Label (SPL) was submitted to the FDA by New Avon Llc for the product Ultra Color Absolute (NDC 10096-0325). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
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