Label: SYS- octinoxate, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68990-001-01 - Packager: AdvoCare International L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 18, 2014
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use water resistant sunscreen if 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
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Inactive ingredients
water, cyclopentasiloxane, glycerin, cetyl ethylhexanoate, tribehenin PEG-20 esters, caprylyl methicone, dimethicone, stearic acid, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, polysorbate 80, aluminum hydroxide, squalane, isohexadecane, sodium acrylate/sodium acryloyldimehtyl taurate/acrylamide copolymer, hydroxyacetophenone, dimethicone/PEG-10/15 corosspolymer, cetyl alcohol, nylon-12, linoleic acid, palmitoyl tripeptide-5, 1,2-hexanediol, caprylyl glycol, dextrin, hydrolyzed hibiscus esculentus extract, sodium hyaluronate, xanthan gum, tocopherol, disodium EDTA, sodium hydroxide, vitis vinifera (grape) seed extract, glycine soja (Soybean) oil, fragrance, algae extract, glycine soja (soybean) seed extract, ergocalciferol, linolenic acid, camellia sinensis leaf extract, aloe barbadensis leaf extract, potassium sorbate, sodium benzoate, ascorbic acid
- Other Information
- Questions or comments?
- Principal Display
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INGREDIENTS AND APPEARANCE
SYS
octinoxate, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68990-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9) DIMETHICONE (UNII: 92RU3N3Y1O) STEARIC ACID (UNII: 4ELV7Z65AP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SQUALANE (UNII: GW89575KF9) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) 4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH) NYLON-12 (UNII: 446U8J075B) LINOLEIC ACID (UNII: 9KJL21T0QJ) PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) ICODEXTRIN (UNII: 2NX48Z0A9G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) XANTHAN GUM (UNII: TTV12P4NEE) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM HYDROXIDE (UNII: 55X04QC32I) VITIS VINIFERA SEED (UNII: C34U15ICXA) SOYBEAN OIL (UNII: 241ATL177A) SOYBEAN (UNII: L7HT8F1ZOD) ERGOCALCIFEROL (UNII: VS041H42XC) LINOLENIC ACID (UNII: 0RBV727H71) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ALOE VERA LEAF (UNII: ZY81Z83H0X) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68990-001-01 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2014 Labeler - AdvoCare International L.P. (799232707)